A Study to Assess Two Forms of The Study Medicine (Ritlecitinib) in Healthy Adult Participants

Sponsor
Pfizer
Study ID
NCT05852340
Phase
PHASE1
Status
Completed

Conditions

  • Adult
  • Healthy Volunteers
  • Pharmacokinetics

Eligibility Criteria

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

Interventions

  • Ritlecitinib — DRUG
    ritlecitinib 1 x 30 mg intact BiC (Treatment Arms A, E) ritlecitinib 1 x 30 mg intact BiC sprinkled on soft foods (Treatment Arms B, C, D)

Study Details

The purpose of this study is to compare if two forms of study medicine, Ritlecitinib, get processed differently in healthy adults. This study is seeking participants who are: * aged 18 or older; * male or female who are healthy as determined by medical assessment ; * Body-mass Index (BMI) of 16 to 32, and a total body weight \> 45kg. The study will take up to 2.5 months, including the screening period. There will be 5 periods in total for this study. Participants will have to stay at the study clinic for at least 11 days. Participants will take Riltecitinib either as sprinkled in Soft Food or as Intact Blend-In Capsule. On day 1 of each period, participants will take Riltecitinib and have blood samples taken both before and afterwards. Participants will also answer questions for taste assessment purpose. A follow-up phone call will be made at 28 to 35 days after the last study period.

Key Dates

Start date
May 9, 2023
Status verified
Oct 2024
Primary completion
Jun 15, 2023
Completion
Jul 24, 2023

Study Design

Enrollment
12 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Treatment A
    ritlecitinib 1 x 30 milligram (mg) intact blend-in-capsule (BiC) in fasted state
  • Active Comparator: Treatment B
    contents of ritlecitinib 1 x 30 mg intact BiC sprinkled on strawberry jam in fasted state
  • Active Comparator: Treatment C
    contents of ritlecitinib 1 x 30 mg intact BiC sprinkled on yoghurt in fasted state
  • Active Comparator: Treatment D
    contents of ritlecitinib 1 x 30 mg intact BiC sprinkled on applesauce in fasted state
  • Active Comparator: Treatment E
    ritlecitinib 1 x 30 mg intact BiC given with high fat meal

Primary Outcome Measure

Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Ritlecitinib [ Time Frame: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12 and 24 hours post-dose on Day 1 of each period. Each treatment period lasted 24 hours. Dosing of each period was separated by at least a 48-hour washout interval. ]

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