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

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Pfizer
Study ID
NCT06369454
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Ritlecitinib — DRUG
    Ritlecitinib 100 milligrams (mg) will be provided as either solution or capsule formulation (2 capsules of 50 mg) with 153Sm2O3

Study Details

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.

Key Dates

Start date
May 3, 2024
Status verified
Aug 2024
Primary completion
Jul 31, 2024
Completion
Jul 31, 2024

Study Design

Enrollment
12 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Treatment Sequence 1
    Ritlecitinib 100 mg solution (fasted, Period 1), followed by ritlecitinib 100 mg MR capsule with 153Sm2O3 (fasted, Period 2), and followed by ritlecitinib 100 mg MR capsule with 153Sm2O3 (fed, Period 3).
  • Experimental: Treatment Sequence 2
    Ritlecitinib 100 mg solution (fasted, Period 1), followed by ritlecitinib 100 mg MR capsule with 153Sm2O3 (fed, Period 2), and followed by ritlecitinib 100 mg MR capsule with 153Sm2O3 (fasted, Period 3).

Primary Outcome Measure

Site of capsule disintegration and MR microsphere dispersion [ Time Frame: up to 48 hours post dose or as long as radioactivity is present in the GI tract (if it is shorter than 48 hours) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Scintipharma - Lexington - Maywick View LaneLexingtonKentucky40504-

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