Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 10 participants.
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.
Interventions
- DRUG tolebrutinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2022-03-18 |
| Est. Completion | 2022-05-24 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05283915
The ClinicalTrials.gov registry entry for NCT05283915 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which tolebrutinib is the first listed.
NCT05283915 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.