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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Study Focus
Sponsor & Location
Pfizer
Timeline & Enrollment
Phase 1
May 01, 2024
Aug 03, 2024
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
Data Source
ClinicalTrials.gov
NCT06369454
Non-Device Trial

