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NCT05282030 · ClinicalTrials.gov registry record · Phase 1
Study to Assess the Plasma Concentration of Tolebrutinib Given as a Tablet to Adult Participants With Renal Impairment Compared to Healthy Participants.
A Phase 1 study of Renal Impairment, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 4
- Study locations
NCT05282030: Completed Phase 1 study of Renal Impairment, sponsored by Sanofi.
NCT05282030 is a Phase 1 study of Renal Impairment that has completed, run by Sanofi. The registered enrollment target is 22 participants, below the 34-participant average among 32 other Renal Impairment trials with a reported enrollment target (35% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05282030, a Phase 1 study of Renal Impairment, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 4
- Study locations
Study Summary
The purpose of this parallel group, Phase 1, open-label, 2-arm study is to assess the effect of severe (Part A) and moderate (Part B, conditional) renal impairment (RI) on pharmacokinetics (PK), safety and tolerability of tolebrutinib tablets compared with normal renal 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
Conditions Studied
Interventions
- DRUG tolebrutinib
Study Locations (4)
Florida
- Clinical Pharmacology of Miami Site Number : 8400002 - Miami
Minnesota
- Nucleus Network Site Number : 8400001 - Saint Paul
Tennessee
- Volunteer Research Group-NOCCR Site Number : 8400003 - Knoxville
Other
- Investigational Site Number : 2760001 - Kiel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2022-03-10 |
| Est. Completion | 2022-08-02 |
| Phase | Phase 1 |
What the finished NCT05282030 record still lists
NCT05282030 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 34-participant average among 32 other Renal Impairment trials with a reported enrollment target (35% lower).
The record links to 1 condition, with Renal Impairment appearing as the primary indexed condition, and to 1 intervention - of which tolebrutinib is the first listed.
NCT05282030 reports a single indexed study location in Florida, Minnesota, Tennessee.
Frequently Asked Questions
What is clinical trial NCT05282030 about?
NCT05282030 is a clinical study titled "Study to Assess the Plasma Concentration of Tolebrutinib Given as a Tablet to Adult Participants With Renal Impairment Compared to Healthy Participants.". The purpose of this parallel group, Phase 1, open-label, 2-arm study is to assess the effect of severe (Part A) and moderate (Part B, conditional) renal impairment (RI) on pharmacokinetics (PK), safety and tolerability of tolebrutinib tablets compared with normal renal function, in male and female p...
What is the current status of trial NCT05282030?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2022-03-10. Estimated completion is 2022-08-02.
What conditions does trial NCT05282030 study?
This clinical trial studies the following conditions: Renal Impairment.
What interventions are being tested in trial NCT05282030?
The interventions under investigation include: tolebrutinib (DRUG).
Who is sponsoring clinical trial NCT05282030?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05282030 being conducted?
This trial has 4 study locations across Florida, Minnesota, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05282030's enrollment target sits among peer trials
22 26th of 32 higher than 7 of 32 other Renal Impairment trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Renal Impairment 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.
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