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A Study of Mass Balance, Pharmacokinetics, Metabolite Profile, and Metabolite Identification of BIIB122/DNL151 in Healthy Male Subjects

NCT05119790 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2021-12-07

No results posted yet for this study

Summary

This is a single-center, non-randomized, open-label Phase 1 study to determine the absorption, metabolism, and excretion (AME) of BIIB122 (DNL151) following administration of a single oral dose of \[14C\] BIIB122 (\[14C\] DNL151) following a fast. The mass balance, excretion, and PK of BIIB122 (DNL151) will be used to evaluate AME.

Conditions

  • Healthy Volunteers

Interventions

DRUG

[14C] BIIB122 ([14C] DNL151)

Oral dose

Sponsors & Collaborators

  • Denali Therapeutics Inc.

    collaborator INDUSTRY

  • Biogen

    lead INDUSTRY

Principal Investigators

  • Medical Director · Denali Therapeutics Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-27
Primary Completion
2021-11-05
Completion
2021-11-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05119790 on ClinicalTrials.gov