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drugset / Trial / NCT04748926

Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants

NCT04748926 ↗

Phase 1 Completed 24 enrolled Principia Biopharma, a Sanofi Company
RandomizedCrossoverOpen-labelOther

Summary

Primary Objective: * To evaluate the impact of food on the pharmacokinetics (PK) of rilzabrutinib following single oral doses to healthy subjects. * To evaluate the impact of formulation on the PK of rilzabrutinib following single oral doses to healthy subjects Secondary Objective: \- To assess the safety and tolerability of single oral doses of rilzabrutinib administered under fasted and fed conditions

Timeline

Start
2021-04-07
Primary completion
2021-05-21
Completion
2021-05-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Rilzabrutinib Small molecule — Oral

Indications

No indication recorded.