At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A PHASE 1, RANDOMIZED, OPEN-LABEL, CROSSOVER STUDY TO ESTIMATE THE RELATIVE BIOAVAILABILITY OF PEDIATRIC RITLECITINIB (PF-06651600) SPRINKLED IN APPLESAUCE, YOGHURT AND STRAWBERRY JAM RELATIVE TO INTACT BLEND-IN CAPSULE OF RITLECITINIB AND THE EFFECT OF FOOD ON THE BIOAVAILABILITY OF THE INTACT BLEND-IN CAPSULE DOSAGE FORMULATION OF RITLECITINIB IN HEALTHY ADULT PARTICIPANTS
In Brief
A Phase 1 clinical trial evaluating Ritlecitinib for Healthy Volunteers and 2 related conditions. Completed, enrolled 12 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
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)