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NCT05097716 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Effect of Multiple-Dose Ritlecitinib on the Pharmacokinetics (PK) of Tolbutamide
A Phase 1 study of Healthy Volunteers, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT05097716: Completed Phase 1 study of Healthy Volunteers, sponsored by Pfizer.
NCT05097716 is a Phase 1 study of Healthy Volunteers that has completed, run by Pfizer. The registered enrollment target is 12 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05097716, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase 1, 2-period, multiple-dose, open-label, single fixed sequence study of the effect of ritlecitinib on tolbutamide pharmacokinetics in healthy participants.
Primary Outcome
Cmax was defined as maximum observed plasma concentration. The determination method of Cmax was observing directly from data.
Conditions Studied
Interventions
- DRUG Ritlecitinib
- DRUG Tolbutamide
Study Locations (1)
Connecticut
- New Haven Clinical Research Unit - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2021-11-02 |
| Est. Completion | 2022-01-10 |
| Phase | Phase 1 |
What the finished NCT05097716 record still lists
NCT05097716 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which Ritlecitinib is the first listed.
NCT05097716 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT05097716 about?
NCT05097716 is a clinical study titled "Study to Evaluate the Effect of Multiple-Dose Ritlecitinib on the Pharmacokinetics (PK) of Tolbutamide". This is a Phase 1, 2-period, multiple-dose, open-label, single fixed sequence study of the effect of ritlecitinib on tolbutamide pharmacokinetics in healthy participants.
What is the current status of trial NCT05097716?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2021-11-02. Estimated completion is 2022-01-10.
What conditions does trial NCT05097716 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT05097716?
The interventions under investigation include: Ritlecitinib (DRUG), Tolbutamide (DRUG).
Who is sponsoring clinical trial NCT05097716?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05097716 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05097716's enrollment target sits among peer trials
12 252nd of 283 higher than 26 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers 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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