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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 - Trial NCT06369454

Access comprehensive clinical trial information for NCT06369454 through Pure Global AI's free database. This Phase 1 trial is sponsored by Pfizer and is currently Not yet recruiting. The study focuses on Healthy Volunteers. Target enrollment is 12 participants.

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NCT06369454
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06369454
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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, 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

Study Focus

Healthy Volunteers

Ritlecitinib

Interventional

drug

Sponsor & Location

Pfizer

Timeline & Enrollment

Phase 1

May 01, 2024

Aug 03, 2024

12 participants

Primary Outcome

Site of capsule disintegration and MR microsphere dispersion,Gastric emptying time,Small intestine residence/transit time,Colon arrival time,Colon (ascending, transverse, descending) residence/transit time,Total transit time

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.

ICD-10 Classifications

Healthy person accompanying sick person
Routine general health check-up of armed forces
Routine general health check-up of sports teams
Routine general health check-up of inhabitants of institutions

Data Source

ClinicalTrials.gov

NCT06369454

Non-Device Trial