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
Public ClinicalTrials.gov record NCT06369454. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A PHASE 1, RANDOMIZED, OPEN-LABEL, 2-SEQUENCE, 3-PERIOD STUDY TO CHARACTERIZE THE GASTROINTESTINAL TRANSIT OF A MODIFIED-RELEASE CAPSULE FORMULATION UNDER FASTED AND FED CONDITIONS BY SINGLE LABEL GAMMA SCINTIGRAPHY IN HEALTHY MALE ADULT PARTICIPANTS
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06369454
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 12 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 2, 2024
- Primary completion
- Jul 30, 2024
- Completion
- Jul 30, 2024
- Last update posted
- Aug 27, 2024
2024
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Scintipharma - Lexington - Maywick View Lane | Lexington | Kentucky | 40504 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06369454, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 27, 2024 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06369454 live on ClinicalTrials.gov.