A Study to Learn About Three Forms of The Study Medicine (Ritlecitinib) in Healthy Adults

Healthy Volunteers Clinical Trial

Official title: A PHASE 1, OPEN-LABEL STUDY IN HEALTHY PARTICIPANTS TO INVESTIGATE THE PHARMACOKINETICS OF RITLECITINIB FOLLOWING SINGLE ORAL ADMINISTRATION OF MODIFIED RELEASE FORMULATIONS UNDER FED AND FASTED CONDITIONS

Status Completed

Clinical Trial Summary

The purpose of this study is to compare if three forms of study medicine (called ritlecitinib) get processed differently in healthy adults.

This study is seeking healthy participants who have:

• Aged 18 years or older;

• male or female 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 three different forms (solution, capsule 1 and capsule 2).

The study will take up to 2.5 months, including the screening period and follow-up phone call. Participants will have to stay at the study clinic for at least 13 days. There will be 4 periods in total for this study. On day 1 of each period, participants will take one form of Riltecitinib without food for the first three 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.

Clinical Trial Description

Ritlecitinib is a covalent and irreversible inhibitor of JAK3 with high selectivity over the other JAK isoforms (JAK1, JAK2, and TYK2). Ritlecitinib also inhibits irreversibly the TEC family kinases with selectivity over the broader human kinome. Treatment with ritlecitinib is expected to inhibit the inflammatory pathways mediated by IL 7, IL 15 and IL 21, all implicated in UC, CD, AA, RA, and vitiligo and therefore under development in these indications. Moreover, due to lack of activity against the other JAK isoforms, ritlecitinib is expected to spare immunoregulatory cytokines such as IL 10, IL 27 and IL 35, which are critical to the maintenance of immunosuppressive functions and immune homeostasis.

This study aims to investigate the pharmacokinetics (PK) and relative bioavailability of 2 new modified release (MR) capsule formulations of ritlecitinib, MR1 (release duration: 6-8 hours) and MR2 (release duration:13 15 hours) as single doses in fasted and fed conditions.

This is a single dose, open-label, randomized, 4-period, 6-sequence crossover study in a single cohort of approximately 12 healthy participants randomized to one of the sequences (containing 1 solution and 2 modified release [MR1 and MR2] capsule formulations of ritlecitinib) described in the table below. The first 3 periods are under fasted condition and the fourth period is under fed condition to investigate the effect of food on the PK of MR1 and MR2.

For a given participant, the total study duration from screening to follow-up phone call will be between approximately 8 to 11 weeks.

Screening will occur within 28 days prior to the first dose of the study intervention. Each participant will go through Periods 1 through 4 and dosing in each treatment period will be separated by at least 3 days to minimize any carryover effect.

Venous PK blood samples for PK analysis will be collected pre-dose and post-dose in each period. ;

Related Conditions & MeSH terms

• Healthy Volunteers

• NCT number: NCT06172348
• Study type: Interventional
• Source: Pfizer
• Status: Completed
• Phase: Phase 1
• Start date: February 1, 2024
• Completion date: March 28, 2024