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NCT03961932 · ClinicalTrials.gov registry record · Phase 1
Safety and Pharmacokinetics of Linzagolix in Female Subjects With Normal and Impaired Renal Function
A Phase 1 study, sponsored by ObsEva.
- Completed
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
NCT03961932: Completed Phase 1 study, sponsored by ObsEva.
NCT03961932 is a Phase 1 study that has completed, run by ObsEva. The registered enrollment target is 33 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03961932, a Phase 1 study, has completed, sponsored by ObsEva.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 33 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 renal function compared to matched control subjects with normal renal function
Primary Outcome
Measurement of effect of renal 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 | 33 participants |
| Start Date | 2019-05-15 |
| Est. Completion | 2020-01-31 |
| Phase | Phase 1 |
What the finished NCT03961932 record still lists
NCT03961932 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 1 intervention - of which Linzagolix is the first listed.
NCT03961932 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03961932 about?
NCT03961932 is a clinical study titled "Safety and Pharmacokinetics of Linzagolix in Female Subjects With Normal and Impaired Renal Function". The primary objective of this study is to assess the pharmacokinetics (PK) of linzagolix in subjects with varying degrees of impaired renal function compared to matched control subjects with normal renal function
What is the current status of trial NCT03961932?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2019-05-15. Estimated completion is 2020-01-31.
What interventions are being tested in trial NCT03961932?
The interventions under investigation include: Linzagolix (DRUG).
Who is sponsoring clinical trial NCT03961932?
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 NCT03961932's enrollment target sits among peer trials
33 1280th of 2000 higher than 705 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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