ZYH1 first-in-human study

13 evidence topics · 2 sources

Objective

Pharmacokinetics, safety, and tolerability objective

“healthy human subjects” (opens the source at this quote in a new tab)

Location and study date

Study conduct dates

“16 June 2005 to 29 November 2005” (opens the source at this quote in a new tab)

Study design

Single-center randomized design

“randomized, double-blind, placebo-controlled, single-centre” (opens the source at this quote in a new tab)

Eligibility criteria

Healthy-volunteer age range

Criterion	Age, years
Minimum	“18”
Maximum	“45”

Treatment

Single-dose range and food/sex substudy

Study component	Dose
Lowest ascending dose, mg	“0.125”
Highest ascending dose, mg	“128”
Food/sex substudy dose, mg	“1”

Study outcomes

Rationale for using pharmacokinetic parameters as the primary endpoint

Not applicable.

Statistical analysis description

Number of participants (Planned and analyzed)

Enrollment accounting

Population	Participants
Unique participants overall	“96”
Part I: healthy men	“88”
Part II: men and women	“16”

Description of analysis sets

Pharmacokinetic analysis

“non-compartmental” (opens the source at this quote in a new tab)

Results

Participant disposition

Part I completion

Population	Participants
Completed Part I	“87”

Baseline characteristics

Part II sex distribution

Sex	Participants
Male	“8”
Female	“8”

Efficacy results

Renal elimination

“Saroglitazar was not eliminated via the renal route.” (opens the source at this quote in a new tab)

Dosage-interval interpretation

“The pharmacokinetics of saroglitazar support a once daily dosage schedule.” (opens the source at this quote in a new tab)

Health-related quality of life and patient-reported outcomes

Not applicable.

Safety results

Serious adverse events

“No serious adverse events were reported.” (opens the source at this quote in a new tab)

Study limitations

Summary

This single-dose study enrolled healthy volunteers, not participants with PBC. Its 96 unique participants included eight men who participated in both parts, so the part-specific enrollments should not be added without accounting for overlap. It does not establish efficacy or repeated-dose safety in PBC.