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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: Completed Phase 1 study, sponsored by Pfizer.

NCT06369454 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

The time and gastrointestinal location where the HPMC capsule(s) disintegrate and disperse the drug formulation.

Interventions

  • DRUG Ritlecitinib

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2024-05-03
Est. Completion 2024-07-31
Phase Phase 1
Pfizer

1,845 total trials

What the finished NCT06369454 record still lists

NCT06369454 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).

The record links to 0 conditions, and to 1 intervention - of which Ritlecitinib is the first listed.

NCT06369454 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT06369454's enrollment target sits among peer trials

12 1852nd of 2000 higher than 90 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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Source: ClinicalTrials.gov NCT06369454, the US trial registry maintained by the National Library of Medicine. NCT06369454 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.