Objectives in the protocol and statistical plan summary

“To investigate the effect of esomeprazole on the pharmacokinetics of pritelivir” (opens the source at this quote in a new tab)
“To investigate the pharmacokinetics of pritelivir metabolites AIC090015, AIC090105 and AIC090015-acylglucuronides” (opens the source at this quote in a new tab)
“To investigate the safety and tolerability of pritelivir” (opens the source at this quote in a new tab)

Objective in the registry record

“To investigate the effect of esomeprazole (ESO) on the pharmacokinetics of pritelivir (PTV), and to investigate the safety and tolerability of PTV.” (opens the source at this quote in a new tab)

Registry dates and status

Field	Quoted record
Study start (actual)	“2020-07-13”
Primary completion (actual)	“2020-10-13”
Study completion (actual)	“2020-10-13”
First submitted	“2022-08-22”
First posted	“2022-08-24”
Results first submitted	“2022-09-16”
Results first posted	“2023-09-15”
Last update posted	“2024-02-22”
Recruitment status	“Completed”

Registry study site

Field	Quoted record
Number of locations	“This study has 1 location”
Location	“Cincinnati, Ohio, United States, 45227”
Facility	“Medpace Clinical Pharmacology”

Trial center, planned trial period, and document dates

Field	Quoted record
Trial center	“Medpace Clinical Pharmacology 5355 Medpace Way, Cincinnati, Ohio 45227, USA”
Planned first participant first visit	“Jul 2020”
Planned last participant last visit	“Sep 2020”
Phase of development	“Phase 1”
Clinical trial protocol	“Clinical Trial Protocol, V1.0: 04Jun2020”
Pharmacokinetic statistical analysis plan	“Pharmacokinetic Statistical Analysis Plan, V1.0: 01Jul2020”
Safety statistical analysis plan	“Safety Statistical Analysis Plan, V2.0: 21Jul2020”
Summary document	“Summary of the Clinical Trial Protocol and Statistical Plan, V1.0: 16Sep2022”

Design as conducted, in the registry record

“This was a single-center, open-label, 2-period, fixed-sequence Phase 1 trial in 16 healthy adult male and female subjects (at least 7 subjects per sex).” (opens the source at this quote in a new tab)
“In the first period, subjects received treatment 1 (T1; single dose of 100 mg PTV on Day 1).” (opens the source at this quote in a new tab)
“In the second period, subjects received treatment 2 (T2: 40 mg qd ESO from Day -3 to Day 1 followed by a single dose of 100 mg PTV on Day 1).” (opens the source at this quote in a new tab)
“The wash-out period between PTV administrations in T1 and T2 was at least 4 weeks.” (opens the source at this quote in a new tab)

Registry design fields

Field	Quoted record
Study type	“Interventional”
Phase	“Phase 1”
Allocation	“Non-Randomized”
Interventional model	“Sequential Assignment”
Interventional model description	“Sequence for all subjects: Treatment 1: single dose of 100 mg PTV followed by Wash out period (4weeks) followed by Treatment 2: single dose of 100 mg PTV Day 1 and 40 mg/day ESO from Day -3 to Day 1”
Masking	“None (Open Label)”
Primary purpose	“Other”
Enrollment (actual)	“16”

Design as planned, in the protocol and statistical plan summary

“This will be a single-center, open-label, 2-period, fixed-sequence Phase 1 trial in 18 healthy adult male and female subjects (at least 7 subjects per sex).” (opens the source at this quote in a new tab)
“All subjects will receive treatment 1 (T1; single dose of 100 mg pritelivir will be administered on Day 1) in the first period, followed by treatment 2 (T2; single dose of 100 mg pritelivir will be administered on Day 1 and 40 mg esomeprazole will be administered qd from Day -3 to Day 1) in the second period.” (opens the source at this quote in a new tab)
“The wash-out period between pritelivir administrations in T1 and T2 is at least 4 weeks.” (opens the source at this quote in a new tab)

Pharmacokinetic sampling period

“Pharmacokinetic profile will be determined in each period on Day 1 for 360 hours.” (opens the source at this quote in a new tab)

Clinic stay through day 5 of each period, as stated in a dietary restriction

“from 24 hours before PTV dosing on Day 1 until release from the clinic on Day 5 of each period” (opens the source at this quote in a new tab)

Age, sex, and healthy volunteer status in the registry record

Field	Quoted record
Ages eligible for study	“18 Years to 45 Years”
Sexes eligible for study	“All”
Accepts healthy volunteers	“Yes”

Main criteria for inclusion in the protocol and statistical plan summary

“Healthy adult male and female subjects (at least 7 subjects per sex) of any ethnic origin, aged 18 to 45 years inclusive.” (opens the source at this quote in a new tab)

Inclusion criteria: health status, consent, and body weight

“Subjects had to have the ability to understand and sign written informed consent, which had to be obtained prior to any trial-related procedures being completed;” (opens the source at this quote in a new tab)
“Healthy male and female subjects of any ethnic origin, aged between 18 and 45 years (inclusive) assessed as healthy based on a pre-trial examination including medical history, physical examination, blood pressure, pulse rate, electrocardiogram (ECG) assessment, and clinical laboratory results.” (opens the source at this quote in a new tab)
“Normal body weight as evidenced by a Body Mass Index (BMI) ≥18.0 and ≤32.0 kg/m2, and a body weight ≥50.0 kg at Screening.” (opens the source at this quote in a new tab)
“Subject agreed to pharmacogenetic blood sampling.” (opens the source at this quote in a new tab)

Inclusion criteria: contraception and pregnancy testing

“Female subjects of non-childbearing potential had to be either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy at least 26 weeks prior to Screening) or postmenopausal, defined as spontaneous amenorrhea for at least 2 years, with follicle-stimulating hormone (FSH) in the postmenopausal range at Screening based on the central laboratory's ranges.” (opens the source at this quote in a new tab)
“Female subjects of childbearing potential (ie, ovulating, premenopausal, and not surgically sterile) and all male subjects had to use a medically accepted contraceptive regimen during their participation in the trial and for 90 days after the last administration of trial drug.” (opens the source at this quote in a new tab)
“Medically accepted contraceptive methods were defined as those with 90% or greater efficacy.” (opens the source at this quote in a new tab)
“Male subjects had to agree to abstain from sperm donation and not plan to father a child (including sperm donation) through 90 days after administration of the last dose of trial drug.” (opens the source at this quote in a new tab)
“In women: a negative serum beta-human chorionic gonadotropin (β-HCG) test at Screening and negative urine β-HCG test at Admission in each Treatment Period.” (opens the source at this quote in a new tab)

Inclusion criteria: infection and drug screening

“Subjects had to have a negative test result for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb), and human immunodeficiency virus (HIV) at Screening;” (opens the source at this quote in a new tab)
“Subjects had to have negative urine tests for drugs of abuse (metamphetamines, amphetamines, 3,4-Methylendioxyamphetamin (MDMA), barbiturates, benzodiazepines, cannabinoids, opioids, cocaine and tricyclic antidepressants) and negative breath alcohol tests at Screening and Admission in each Treatment Period.” (opens the source at this quote in a new tab)

Exclusion criteria: medical history

“History or current evidence of clinically relevant allergies or idiosyncrasy to drugs or food” (opens the source at this quote in a new tab)
“History of allergic reactions to any active or inactive ingredient(s) of the trial medication(s)” (opens the source at this quote in a new tab)
“History or current evidence of any clinically relevant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrinological, metabolic, neurological, psychiatric, or other disease suspected to influence pharmacokinetics or safety of PTV” (opens the source at this quote in a new tab)
“History of malignancy” (opens the source at this quote in a new tab)
“Febrile or infectious illness within 5 days prior to administration of Investigational Medicinal Product” (opens the source at this quote in a new tab)
“Chronic or clinically relevant acute infections” (opens the source at this quote in a new tab)
“Diseases or surgery of the gastrointestinal tract which may have interfered with drug absorption (note: this was not applicable for minor abdominal surgery such as eg, appendectomy and herniotomy)” (opens the source at this quote in a new tab)
“Subject was lactating or breastfeeding” (opens the source at this quote in a new tab)

Exclusion criteria: vital signs, electrocardiogram, and laboratory values

“Resting pulse rate after 5 minutes in supine position at Screening and Day -1 of Treatment Period 1: <45 or >100 beats per minute (bpm), if out of range, up to one repeat assessment was allowed” (opens the source at this quote in a new tab)
“systolic blood pressure <90 or >145 mmHg” (opens the source at this quote in a new tab)
“diastolic blood pressure <40 or >95 mmHg, if out of range, up to one repeat assessment was allowed” (opens the source at this quote in a new tab)
“ECG abnormalities of clinical relevance (eg, QTc according to Fridericia: QTc >450 ms in males and >470 ms in females; PR ≥220 ms)” (opens the source at this quote in a new tab)
“Clinically relevant abnormalities in clinical chemical, hematological or any other laboratory variables” (opens the source at this quote in a new tab)
“Diagnosed to be COVID-19 positive by polymerase chain reaction (PCR) testing (SARS-CoV-2 RT-PCR positive) of a respiratory specimen (preferably a nasopharyngeal swab) on Day -2 of Treatment Period 1” (opens the source at this quote in a new tab)

Exclusion criteria: medications, investigational products, and blood donation

“Use of any medication (incl. over-the-counter [OTC] medication) within 2 weeks before first drug administration or within less than 10 times the elimination half-life of the respective drug, or anticipated concomitant medication during the treatment periods.” (opens the source at this quote in a new tab)
“Use of hormonal contraceptives was allowed.” (opens the source at this quote in a new tab)
“Single intake of a drug may have been accepted if judged by the Investigators to have no clinical relevance and no relevance for the trial objectives.” (opens the source at this quote in a new tab)
“Limited amounts of acetaminophen were allowed to treat painful intercurrent adverse events (eg, headache, migraine).” (opens the source at this quote in a new tab)
“Receipt of any Investigational Medicinal Product (IMP) within a time period equal to 10 half-lives of the product, if known, or a minimum of 30 days prior to trial drug administration.” (opens the source at this quote in a new tab)
“Blood donation or loss of 550 mL or more within the last 30 days before start of Screening (Pre-trial examination)” (opens the source at this quote in a new tab)

Exclusion criteria: diet, alcohol, and tobacco

“Consumption of any (eg, CYP1A2, CYP3A4) enzyme inducing or inhibiting aliments and beverages (eg, but not limited to broccoli, Brussels sprout, grapefruit, grapefruit juice, Seville orange, star fruit, tonic water, bitter lemon etc.) within 2 weeks prior to the Screening (Pre-trial examination)” (opens the source at this quote in a new tab)
“Consumption of alcohol and tobacco products within 48 hours prior to admission to the clinic until discharge of each period” (opens the source at this quote in a new tab)
“Vegetarian diet or other dietary habits which would have precluded the subject's acceptance of standardized meals” (opens the source at this quote in a new tab)
“Smoking of more than 10 cigarettes/cigars/pipes per Day and/or inability to refrain from smoking during confinement” (opens the source at this quote in a new tab)
“Intake of more than 12 units of alcohol per week (one unit of alcohol equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits)” (opens the source at this quote in a new tab)

Treatment periods in the registry record

Period	Arm	Quoted regimen
Period 1	“Experimental: 100 mg pritelivir”	“Single dose 100 mg pritelivir (PTV) administered day 1”
Period 2	“Experimental: 40 mg qd ESO and 100 mg pritelivir”	“40 mg qd ESO Day -3 to Day1. Single dose of 100 mg PTV on Day 1”

Products, doses, and duration in the protocol and statistical plan summary

Field	Quoted record
Pritelivir product	“Oral 100 mg pritelivir tablets”
Esomeprazole product	“Oral 40 mg esomeprazole tablets (Nexium®)”
Pritelivir in each treatment period	“Pritelivir: single dose of 100 mg on Day 1”
Esomeprazole in treatment period 2	“Esomeprazole: 40 mg qd from Day -3 to Day 1, inclusive”
Duration of treatment period 2	“In Treatment Period 2: 4 days”

Fasted administration

“to evaluate the effect of esomeprazole on pritelivir PK under fasted conditions.” (opens the source at this quote in a new tab)

Regimen as described in the prescribing information

“Co-administration of a single oral dose of 100 mg pritelivir (on Day 1) with esomeprazole 40 mg once daily (from Day -3 to Day 1; 4 days total)” (opens the prescribing information at this quote)

Primary pharmacokinetic variables

“AUC0-∞, AUC0-last, Cmax of pritelivir in plasma” (opens the source at this quote in a new tab)

Primary outcome measures in the registry record

Outcome measure	Quoted description	Time frame
“PK - Cmax”	“Cmax - the maximum observed plasma concentration”	“15 days”
“PK - AUC(0-infinity) and AUC(0-last)”	“AUC0-∞ - area under the analyte vs time concentration curve from time of administration up to infinity, calculated as AUC0-∞ = AUC0-last + (Clast / λz)”“AUC0-last - area under the analyte vs. time concentration curve from time of administration up to the time of the last quantifiable concentration, calculated by linear up/ln down summation”	“15 days”

Clinical relevance of reduced pritelivir exposure in the prescribing information

“Elevation of gastric pH may decrease the systemic bioavailability of HOVILPRI” (opens the prescribing information at this quote)
“which may reduce its effectiveness or cause drug resistance to HOVILPRI” (opens the prescribing information at this quote)

Secondary pharmacokinetic variables

“tmax, tlag, t1/2z, CL/F, Vd /F, MRT of pritelivir in plasma” (opens the source at this quote in a new tab)
“The ratio between each of the metabolites AIC090015, AIC090105 and AIC090015-acyl glucuronides versus pritelivir will be calculated for AUC0-∞, AUC0-last” (opens the source at this quote in a new tab)

Secondary outcome measures in the registry record

Outcome measure	Quoted description
“PK - Tmax and Tlag”	“tmax - time to reach the maximal observed analyte concentration and tlag - time period between the time of dosing and the time of the first measurable concentration”
“PK - λz”	“λz - the apparent terminal elimination rate constant, determined by linear regression of terminal points of the ln-linear analyte concentration-time curve”
“PK t1/2z”	“t1/2z - the apparent terminal elimination half-life calculated as: t1/2z = 0.693 / λz”
“PK - CL/F”	“CL/F - total apparent clearance of drug following single dose e.v. administration calculated as: CL/F = Dose / AUC0-∞”
“V d/F”	“V d/F - apparent volume of distribution after a single dose e.v. administration calculated as Vd/F = Dose e.v. / (λz * AUC0-∞)”

Safety variables

“Overall tolerability” (opens the source at this quote in a new tab)
“Nature, frequency, duration, severity and causality of adverse events” (opens the source at this quote in a new tab)
“Clinical laboratory parameters” (opens the source at this quote in a new tab)
“Vital signs (blood pressure, pulse rate)” (opens the source at this quote in a new tab)
“Standard 12-lead ECG” (opens the source at this quote in a new tab)

Pharmacogenomic analysis

“Post-hoc analysis of alleles associated with altered drug metabolism/ disposition may be determined.” (opens the source at this quote in a new tab)

Planned number of participants

“Number of subjects (planned): 18” (opens the source at this quote in a new tab)

Participants enrolled and analyzed on the registry

Population	Pritelivir 100 mg alone	Esomeprazole 40 mg and pritelivir 100 mg
Analyzed for Cmax, tmax, and tlag	“16”	“15”
Analyzed for AUC(0-last), AUC(0-infinity), λz, t1/2z, CL/F, and Vd/F	“15”	“15”

Participants in the pharmacokinetic comparison reported in the prescribing information

Field	Quoted record
Number of participants included in the pharmacokinetic analysis	“15”

Pharmacokinetic set and safety set

“The Pharmacokinetic Set (PKS) will include all subjects in the Safety Set (SS) with at least 1 plasma concentration time point for inclusion in the PK analysis.” (opens the source at this quote in a new tab)
“The PKS will be used for the PK analyses.” (opens the source at this quote in a new tab)
“Safety data analysis will be conducted on the Safety Set.” (opens the source at this quote in a new tab)

Analysis of relative bioavailability

“The relative bioavailability of pritelivir with respect to the primary variables AUC0-∞, AUC0-last and Cmax will be explored based on the log transformed data with an analysis of variance model with treatment (as fixed effect) and subject (as random effect).” (opens the source at this quote in a new tab)
“Point estimates (GMR) and 90% confidence intervals (90% CIs) will be computed for the ratio T2 (test) /T1 (reference)” (opens the source at this quote in a new tab)

Descriptive statistics for pharmacokinetic data

“Descriptive statistics will be calculated for plasma concentrations of pritelivir and derived PK parameters.” (opens the source at this quote in a new tab)
“Statistics include sample size (n), mean, standard deviation (SD), %CV, geometric mean, median, minimum and maximum.” (opens the source at this quote in a new tab)

Safety analysis and electrocardiogram analysis

“Statistical analysis of the safety data will be limited to descriptive summaries.” (opens the source at this quote in a new tab)
“Incidences of treatment-emergent adverse events (TEAE) that began after the start of trial treatment (post-dose on Day 1 to End of trial examination) will be summarized at 3 levels: the overall subject level (occurrence of at least one TEAE), primary System Organ Class level, and preferred term level.” (opens the source at this quote in a new tab)
“In addition, 12-lead ECGs will be analyzed with a focus on the incidence and extent of QTc prolongation.” (opens the source at this quote in a new tab)
“QTc will be calculated according to Fridericia formula.” (opens the source at this quote in a new tab)

Baseline analysis population posted with the registry results

Analysis	Quoted population description
Baseline characteristics	“Safety Set”

Enrollment and completion by treatment period

“16 subjects enrolled in PTV 100 mg (T1), 15 completed.” (opens the source at this quote in a new tab)
“The 15 completed were enrolled into ESO 40 mg/PTV 100 mg (T2)” (opens the source at this quote in a new tab)

Participant flow for the overall study

Milestone	Participants
Started	“16”
Completed	“15”
Not completed	“1”
Not completed: withdrawal by subject	“1”

Age, sex, and ethnicity

Characteristic	All participants
Participants	“16”
Age in years, mean (standard deviation)	“29.6 (8.20)”
Female, count and percentage	“5”“31.3%”
Male, count and percentage	“11”“68.8%”
Hispanic or Latino, count and percentage	“1”“6.3%”
Not Hispanic or Latino, count and percentage	“15”“93.8%”
Ethnicity unknown or not reported, count and percentage	“0”“0.0%”

Race, count and percentage of participants

Characteristic	All participants
American Indian or Alaska Native	“0”“0.0%”
Asian	“0”“0.0%”
Native Hawaiian or Other Pacific Islander	“0”“0.0%”
Black or African American	“12”“75.0%”
White	“4”“25.0%”
More than one race	“0”“0.0%”
Race unknown or not reported	“0”“0.0%”

Geometric mean ratios of pritelivir exposure with and without esomeprazole

Parameter	Geometric mean ratio (90% confidence interval), with esomeprazole relative to pritelivir alone
AUC0-inf	“0.41 (0.36, 0.48)”
AUC0-last	“0.41 (0.35, 0.47)”
Cmax	“0.24 (0.20-0.30)”

Percentage decrease in pritelivir exposure with esomeprazole

“decreased Cmax by approximately 76% and AUC by approximately 59% compared to pritelivir administered alone” (opens the prescribing information at this quote)

Primary outcome measures on the registry: maximum concentration and area under the curve

Parameter, mean (standard deviation)	Unit	Pritelivir 100 mg alone	Esomeprazole 40 mg and pritelivir 100 mg
Cmax	“ng/mL”	“1102 (421)”	“282 (141)”
AUC(0-last)	“ng*h/mL”	“67599 (22012)”	“28325 (11071)”
AUC(0-infinity)	“ng*h/mL”	“69140 (22147)”	“29404 (11447)”

Secondary outcome measures on the registry: time to maximum concentration and lag time

Parameter, median (full range)	Unit	Pritelivir 100 mg alone	Esomeprazole 40 mg and pritelivir 100 mg
tmax	“hours”	“3.00 (0.50 to 10.00)”	“8.00 (0.75 to 48.00)”
tlag	“hours”	“0.00 (0.00 to 0.25)”	“0.00 (0.00 to 0.25)”

Secondary outcome measures on the registry: elimination, clearance, and volume of distribution

Parameter, mean (standard deviation)	Unit	Pritelivir 100 mg alone	Esomeprazole 40 mg and pritelivir 100 mg
Terminal elimination rate constant (λz)	“1/h”	“0.0106 (0.0020)”	“0.00970 (0.0018)”
Terminal elimination half-life (t1/2z)	“hours”	“67.7 (12)”	“73.7 (13)”
Apparent clearance (CL/F)	“L/h”	“1.58 (0.46)”	“3.93 (1.6)”
Apparent volume of distribution (Vd/F)	“L”	“157 (63)”	“432 (231)”

Prescribing information warning on acid-reducing agents

“Concomitant use of HOVILPRI with certain acid-reducing agents may reduce pritelivir exposure, potentially resulting in reduced therapeutic effect and development of resistance.” (opens the prescribing information at this quote)
“Avoid concomitant use with certain proton pump inhibitors, and stagger concomitant use with H2-receptor antagonists and antacids” (opens the prescribing information at this quote)

Prescribing information instructions for proton pump inhibitors

“Avoid concomitant use of esomeprazole or rabeprazole with HOVILPRI.” (opens the prescribing information at this quote)
“Avoid concomitant use of omeprazole or lansoprazole at daily doses above 20 mg with HOVILPRI.” (opens the prescribing information at this quote)
“Avoid concomitant use of pantoprazole at daily doses above 40 mg with HOVILPRI” (opens the prescribing information at this quote)
“Concomitant use of omeprazole, lansoprazole, or pantoprazole below the doses listed above is acceptable, as these lower doses do not reduce pritelivir exposure to a clinically relevant extent.” (opens the prescribing information at this quote)

Other acid-reducing agents evaluated in the phase 3 trial, as stated in the prescribing information

“In the Phase 3 trial (PRIOH-1, Parts C-F), pritelivir exposures were evaluated for participants who received concomitant omeprazole or lansoprazole (≤20 mg daily), pantoprazole (≤40 mg daily), or an H2-receptor antagonist (with pritelivir administered at least 2 hours before or 12 hours after the H2-receptor antagonist).” (opens the prescribing information at this quote)
“Pritelivir exposures in participants receiving these acid-reducing agents were not clinically meaningfully different from those in participants who did not receive any acid-reducing agents” (opens the prescribing information at this quote)

Adverse event reporting period

Field	Quoted record
Time frame	“32 days”

Deaths, serious adverse events, and other adverse events

Category	Pritelivir 100 mg alone	Esomeprazole 40 mg and pritelivir 100 mg
All-cause mortality	“0/16 (0.00%)”	“0/15 (0.00%)”
Serious adverse events	“0/16 (0.00%)”	“0/15 (0.00%)”
Other (not including serious) adverse events	“2/16 (12.50%)”	“4/15 (26.67%)”

Adverse events by system organ class and preferred term

System organ class	Preferred term	Pritelivir 100 mg alone, affected / at risk	Esomeprazole 40 mg and pritelivir 100 mg, affected / at risk
Gastrointestinal disorders	“Tooth impacted”	“1/16 (6.25%)”	“0/15 (0.00%)”
Infections and infestations	“Upper respiratory tract infection”	“0/16 (0.00%)”	“1/15 (6.67%)”
Injury, poisoning and procedural complications	“Ankle fracture”	“1/16 (6.25%)”	“0/15 (0.00%)”
Injury, poisoning and procedural complications	“Lumbar vertebral fracture”	“0/16 (0.00%)”	“1/15 (6.67%)”
Injury, poisoning and procedural complications	“Pulmonary contusion”	“0/16 (0.00%)”	“1/15 (6.67%)”
Injury, poisoning and procedural complications	“Skin abrasion”	“1/16 (6.25%)”	“0/15 (0.00%)”
Musculoskeletal and connective tissue disorders	“Myalgia”	“0/16 (0.00%)”	“1/15 (6.67%)”
Nervous system disorders	“Headache”	“0/16 (0.00%)”	“1/15 (6.67%)”

Summary

AIC316-03-I-01 was an open-label, fixed-sequence trial without randomization in 16 healthy adults aged 18 to 45 years at 1 site. Pritelivir was given as a single 100 mg dose under fasted conditions, and esomeprazole 40 mg once daily was the only acid-reducing regimen tested. One participant withdrew before the second period, and 15 participants entered it. The registry posts means and standard deviations; the geometric mean ratios appear in the prescribing information. No metabolite result is posted, and no journal publication of the trial was identified.

Agreement restricting investigator publication

“Principal Investigators are NOT employed by the organization sponsoring the study.” (opens the source at this quote in a new tab)
“There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed” (opens the source at this quote in a new tab)