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NCT03962049 · ClinicalTrials.gov registry record · Phase 1
Safety and Pharmacokinetics Study of Linzagolix in Female Subjects With Normal and Impaired Hepatic Function
A Phase 1 study, sponsored by ObsEva.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT03962049: Completed Phase 1 study, sponsored by ObsEva.
NCT03962049 is a Phase 1 study that has completed, run by ObsEva. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03962049, a Phase 1 study, has completed, sponsored by ObsEva.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
The primary objective of this study is to assess the pharmacokinetics (PK) of linzagolix in subjects with varying degrees of impaired hepatic function compared to match control subjects with normal hepatic function
Primary Outcome
Measurement of effect of hepatic impairment on PK of linzagolix and its metabolite KP017 by assessment of the maximum plasma concentration (Cmax). Cmax directly determined from the plasma concentration-time profiles
Interventions
- DRUG Linzagolix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2019-05-15 |
| Est. Completion | 2019-11-01 |
| Phase | Phase 1 |
What the finished NCT03962049 record still lists
NCT03962049 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 1 intervention - of which Linzagolix is the first listed.
NCT03962049 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03962049 about?
NCT03962049 is a clinical study titled "Safety and Pharmacokinetics Study of Linzagolix in Female Subjects With Normal and Impaired Hepatic Function". The primary objective of this study is to assess the pharmacokinetics (PK) of linzagolix in subjects with varying degrees of impaired hepatic function compared to match control subjects with normal hepatic function
What is the current status of trial NCT03962049?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2019-05-15. Estimated completion is 2019-11-01.
What interventions are being tested in trial NCT03962049?
The interventions under investigation include: Linzagolix (DRUG).
Who is sponsoring clinical trial NCT03962049?
This trial is sponsored by ObsEva, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03962049's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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