At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Ritlecitinib for Healthy Volunteers. Completed, enrolled 12 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Ritlecitinib 100 milligrams (mg) will be provided as either solution or capsule formulation (2 capsules of 50 mg)