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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
12
Ritlecitinib 100 milligrams (mg) will be provided as either solution or capsule formulation (2 capsules of 50 mg) with 153Sm2O3
Scintipharma - Lexington - Maywick View Lane
Lexington, Kentucky, United States
Site of capsule disintegration and MR microsphere dispersion
The time and gastrointestinal location where the HPMC capsule(s) disintegrate and disperse the drug formulation.
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)
Gastric emptying time
Gastric emptying metrics may include a) time of 1st GE; b) time(s) for GE 10%, 25%, 50%, 75%, 90% and complete gastric emptying time GE100%.
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)
Small intestine residence/transit time
Small Intestine transit metrics may include time for 10%, 25%, 50%, 75%, 90% and 100% of the formulation to transit through the small intestine.
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)
Colon arrival time
Arrival time at the colon (ATC) metrics may include a) time(s) for ATC 10%, 25%, 50%, 75%, 90% and 100%.
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)
Colon (ascending, transverse, descending) residence/transit time
The residence time of the formulation in the three primary regions of the large intestine to include the ascending, transverse and descending colon.
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)
Total transit time
Residence time of the formulation in the gastrointestinal tract.
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)
Maximum plasma concentration (Cmax)
Maximum plasma concentration (Cmax)
Time frame: Solution: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose. Capsules: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose.
Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)
Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf) will be calculated if data permit.
Time frame: Solution: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose. Capsules: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose.
Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast)
Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast)
Time frame: Solution: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose. Capsules: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose.
Time for Cmax (Tmax)
Time for Cmax (Tmax)
Time frame: Solution: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose. Capsules: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose.
Terminal half-life (t1/2)
Terminal half-life (t1/2) will be calculated if data permit.
Time frame: Solution: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose. Capsules: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose.
Frequency of adverse events
To evaluate safety and tolerability of ritlecitinib following single oral administration as solution and MR capsule formulations in healthy male adult participants.
Time frame: Baseline up to Day 35
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Frequency of abnormal clinical laboratory tests
To evaluate safety and tolerability of ritlecitinib following single oral administration as solution and MR capsule formulations in healthy male adult participants.
Time frame: Baseline up to Day 11
Frequency of abnormal vital signs
To evaluate safety and tolerability of ritlecitinib following single oral administration as solution and MR capsule formulations in healthy male adult participants.
Time frame: Baseline up to Day 11
Frequency of abnormal 12-lead ECG
To evaluate safety and tolerability of ritlecitinib following single oral administration as solution and MR capsule formulations in healthy male adult participants.
Time frame: Baseline up to Day 11