NCT05005338

A Study to Determine the Absolute Bioavailability of BIIB122/DNL151 in Healthy Subjects

An Open Label Phase 1 Study to Determine the Absolute Bioavailability of Single and Repeated Daily Oral Administration of BIIB122 (DNL151) Utilizing a Microtracer Dose of Intravenously Administered [14C] BIIB122 ([14C] DNL151) to Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a single center, non-randomized, open label Phase 1 study to determine the PK and absolute bioavailability of BIIB122 (DNL151) in 2 conditions: following a single, oral dose of BIIB122 (DNL151) and following consecutive days of oral dosing, approximating steady state.

Detailed description

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	BIIB122 (DNL151)	Oral doses
DRUG	[14C] BIIB122 ([14C] DNL151)	Intravenous doses

Timeline

• Start date: 2021-07-28
• Primary completion: 2021-09-23
• Completion: 2021-09-23
• First posted: 2021-08-13
• Last updated: 2021-11-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study