NCT05195008

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

A Phase 1 Randomized, Blinded, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics, With an Open-Label Target Occupancy Study of BIIB113 in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed description

BIIB113 is a small molecule inhibitor of OGA being evaluated in Alzheimer's disease.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	BIIB113	Administered as specified in the treatment arm.
DRUG	BIIB113-Matching Placebo	Administered as specified in the treatment arm.
DRUG	11^C]BIO-1819578	Administered as specified in the treatment arm.

Timeline

• Start date: 2022-01-24
• Primary completion: 2023-07-10
• Completion: 2023-07-10
• First posted: 2022-01-18
• Last updated: 2024-02-05

Locations

3 sites across 2 countries: Sweden, United Kingdom