drugset / Trial / NCT05152485

A Study to Evaluate the Relative Bioavailability of Two Formulations of BIIB104 and Assess the Effect of Food on the Pharmacokinetics of BIIB104 Following Administration of a Single, Fixed, Oral Dose of BIIB104 in Healthy Participants

NCT05152485

Phase 1 Completed 36 enrolled Biogen
RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objectives of this study are to evaluate the relative bioavailability of the BIIB104 test formulation compared with the reference formulation in healthy Caucasian male adult participants in the fasted state and to assess the impact of food on BIIB104 pharmacokinetic (PK) parameters for the test formulation in healthy Caucasian male adult participants. The secondary objective of the study is to assess the safety and tolerability of BIIB104 0.5 milligrams (mg) test formulation in the fasted and fed states following single-dose administration.

Timeline

Start
2021-12-15
Primary completion
2022-01-31
Completion
2022-01-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator PESAMPATOR Small molecule 0.5 mg Oral

Indications

No indication recorded.