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NCT06369454 · ClinicalTrials.gov registry record · Phase 1
A Study to Learn About How Different Forms of the Study Medicine Called Ritlecitinib Pass the Intestines of Healthy Male Adults When Taken With or Without Food
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT06369454 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 12 participants.
The verdict
NCT06369454, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
The purpose of this study is to learn about how different forms of the study medicine called ritlecitinib pass the intestines of healthy male adults when taken with or without food. This study is seeking healthy participants who have: * Aged 18 years or older; * male who are healthy as determined by medical assessment; * BMI of 16-32 kg/m2, and a total body weight \>45 kg (99 lb). All participants in this study will receive a ritlecitinib oral dose in two different forms (solution without food, capsule with or without food). The study will take up to 3 months, including the screening period and follow-up phone call. Participants will have to stay at the study clinic for at least 11 days. There will be 3 periods in total, and a washout period of at least 3 days between dosings in Period 1 and Period 2, and at least 7 days between dosings in Period 2 and Period 3 for this study. On day 1 of each period, participants will take one form of Riltecitinib without food for the first two periods and with food for the last period. Participants will have blood samples taken both before and after taking ritlecitinib. A follow-up phone call will be made at 28 to 35 days after the last study period.
Interventions
- DRUG Ritlecitinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2024-05-03 |
| Est. Completion | 2024-07-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06369454
The ClinicalTrials.gov registry entry for NCT06369454 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ritlecitinib is the first listed.
NCT06369454 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06369454 about?
NCT06369454 is a clinical study titled "A Study to Learn About How Different Forms of the Study Medicine Called Ritlecitinib Pass the Intestines of Healthy Male Adults When Taken With or Without Food". The purpose of this study is to learn about how different forms of the study medicine called ritlecitinib pass the intestines of healthy male adults when taken with or without food. This study is seeking healthy participants who have: * Aged 18 years or older; * male who are healthy as determined ...
What is the current status of trial NCT06369454?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2024-05-03. Estimated completion is 2024-07-31.
What interventions are being tested in trial NCT06369454?
The interventions under investigation include: Ritlecitinib (DRUG).
Who is sponsoring clinical trial NCT06369454?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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