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drugset / Trial / NCT05195008

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics, With Target Occupancy Study of BIIB113 in Healthy Participants

NCT05195008 ↗

Phase 1 Completed 72 enrolled Biogen
RandomizedSequentialQuadruple-blindTreatment

Summary

Parts A and B: The primary objective of this study is to evaluate the safety and tolerability of single and multiple ascending oral doses of BIIB113 in healthy participants. The secondary objectives of this study are to evaluate the single and multiple oral dose pharmacokinetic (PK) profile of BIIB113 in healthy participants and to evaluate the effect of food on the single oral dose of BIIB113 in healthy participants of Part A cohort 3. Part C: The primary objectives of this study are to evaluate the safety and tolerability of single and multiple ascending oral doses of BIIB113 in healthy participants and to determine target occupancy (TO) as measured by O-GlcNAcase-Positron Emission Tomography (OGA-PET) of single and multiple oral doses of BIIB113 in healthy participants.

Timeline

Start
2022-01-24
Primary completion
2023-07-10
Completion
2023-07-10

Drugs

EvaluationDrugModalityDoseRoute
Subject BIIB113 Small molecule — Oral

Indications

No indication recorded.