Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06369454
Status:
COMPLETED
Last Update Posted:
2024-06-27
First Post:
2024-04-11
Brief Title:
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
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 kgm2 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
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 kgm2 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None