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NCT05283915 · ClinicalTrials.gov registry record · Phase 1
Study to Assess the Plasma Concentration of Tolebrutinib Given as a Tablet to Adult Participants With Mild Hepatic Impairment Compared to Participants With Normal Hepatic Function
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT05283915: Completed Phase 1 study, sponsored by Sanofi.
NCT05283915 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05283915, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
The purpose of this parallel group, Phase 1, open-label, 2-arm, single dose, multi-center study is to assess the effect of mild hepatic impairment on pharmacokinetics (PK), safety and tolerability of tolebrutinib compared with normal hepatic function, in male and female participants aged 18 to 79 years.
Primary Outcome
Area under the plasma concentration (AUC) versus time curve extrapolated to infinity
Interventions
- DRUG tolebrutinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2022-03-18 |
| Est. Completion | 2022-05-24 |
| Phase | Phase 1 |
What the finished NCT05283915 record still lists
NCT05283915 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which tolebrutinib is the first listed.
NCT05283915 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05283915 about?
NCT05283915 is a clinical study titled "Study to Assess the Plasma Concentration of Tolebrutinib Given as a Tablet to Adult Participants With Mild Hepatic Impairment Compared to Participants With Normal Hepatic Function". The purpose of this parallel group, Phase 1, open-label, 2-arm, single dose, multi-center study is to assess the effect of mild hepatic impairment on pharmacokinetics (PK), safety and tolerability of tolebrutinib compared with normal hepatic function, in male and female participants aged 18 to 79 ye...
What is the current status of trial NCT05283915?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2022-03-18. Estimated completion is 2022-05-24.
What interventions are being tested in trial NCT05283915?
The interventions under investigation include: tolebrutinib (DRUG).
Who is sponsoring clinical trial NCT05283915?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05283915's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 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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