LBS-008-CT09
15 evidence topics · 2 sources
Objective
Location and study date
Recruitment location and actual study dates
| Field | Quoted record |
|---|---|
| Site | “CMAX Clinical Research Pty Ltd - Adelaide” |
| First participant enrollment | “7/01/2024” |
| Last participant enrollment | “31/05/2024” |
| Last data collection | “5/07/2024” |
Study design
Registry: overall allocation
Registry: food-effect treatment sequences
Eligibility criteria
Study population
Registered age limits
| Criterion | Quoted record |
|---|---|
| Minimum age | “18 Years” |
| Maximum age | “65 Years” |
Treatment
Tinlarebant dose
Perpetrator-drug regimens
| Drug | Quoted regimen |
|---|---|
| Omeprazole | “40 mg QD” |
| Itraconazole | “200 mg BD” |
| Rifampin | “600 mg QD” |
Study outcomes
Rationale for using cmax and AUCinf as the primary pharmacokinetic endpoints
Not applicable.
Statistical analysis description
Number of participants (Planned and analyzed)
Description of analysis sets
Analysis-set membership and exclusions
No evidence found.
Results
Participant disposition
No evidence found.
Baseline characteristics
No evidence found.
Efficacy results
Drug-interaction pharmacokinetic results
Food-effect pharmacokinetic results
Health-related quality of life and patient-reported outcomes
No evidence found.
Safety results
Study limitations
Summary
This pharmacokinetic study enrolled 49 healthy adult participants and evaluated single-dose tinlarebant exposure with selected interacting drugs or food. Its exposure ratios do not establish long-term clinical efficacy in Stargardt disease. The registry records a non-randomized trial overall, whereas the publication describes a randomized, open-label, two-period interaction study; the registry’s food-effect component specifies randomized fed/fasted sequences. These descriptions should not be interpreted as a randomized comparison of all perpetrator-drug groups.