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

Healthy Volunteers Clinical Trial

Official title:

An Open Label, Phase 1 Study of Mass Balance, Pharmacokinetics, Metabolite Profile, and Metabolite Identification of a Single Oral Dose of [14C]-BIIB122 ([14C] DNL151) in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05119790
• Other study ID #: 283HV102
• Status: Completed
• Phase: Phase 1
• Start date: August 27, 2021
• Est. completion date: November 5, 2021

Study information

• Verified date: November 2021
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: November 5, 2021
• Est. primary completion date: November 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

key Inclusion Criteria:

• For men who choose to have sex with women, either: vasectomy, use of condoms, or sex with a woman who is of non-childbearing potential

• Body mass index =18.0 kg/m2 and =32.0 kg/m2

• Body weight =5.0 kg and =100.0 kg

• Considered to be in good health

• Non-smoker

Key Exclusion Criteria:

• History or presence of any condition or prior surgery that, in the opinion of the investigator, poses a significant risk to subject safety and/or achievement of study objectives

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• [14C] BIIB122 ([14C] DNL151)
Oral dose

Locations

Country	Name	City	State
United States	Pharmaron CPC	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Biogen	Denali Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mass balance (total recovery) following oral administration of a single dose of [14C] BIIB122 ([14C]-DNL151)		43 days
Primary	Percentage of radioactivity recovered in urine following oral administration of a single dose of [14C] BIIB122 ([14C]-DNL151)		43 days
Primary	Percentage of radioactivity recovered in feces following oral administration of a single dose of [14C] BIIB122 ([14C]-DNL151)		43 days
Primary	PK Parameter: The first time to maximum observed concentration (Tmax) for total radioactivity and BIIB122 (DNL151) in blood following oral administration of a single dose of [14C]-BIIB122 ([14C]-DNL151)		43 days
Primary	PK Parameter: Maximum observed plasma concentration (Cmax) occurring at Tmax for total radioactivity and BIIB122 (DNL151) in blood following oral administration of a single dose of [14C]-BIIB122 ([14C]-DNL151)		43 days
Primary	PK Parameter: Area under the concentration-time curve (AUC) of total radioactivity and BIIB122 (DNL151) in blood following oral administration of a single dose of [14C]-BIIB122 ([14C]-DNL151)		43 days
Primary	PK Parameter: Time at which half the drug has been eliminated (T1/2) of total radioactivity and BIIB122 (DNL151) in blood following oral administration of a single dose of [14C]-BIIB122 ([14C]-DNL151)		43 days
Primary	PK Parameter: Apparent systemic clearance (CL/F) of total radioactivity and BIIB122 (DNL151) in blood following oral administration of a single dose of [14C] BIIB122 ([14C]-DNL151)		43 days
Primary	PK Parameter: Apparent volume of distribution (Vz/F) of total reactivity and BIIB122 (DNL151) in blood following oral administration of a single dose of [14C] BIIB122 ([14C]-DNL151)		43 days
Primary	Profiles of [14C] BIIB122 ([14C]-DNL151) and its [14C] metabolites in plasma, urine, and feces following oral administration of a single dose of [14C] BIIB122 ([14C]-DNL151)		43 days
Secondary	Incidence of adverse events (AEs)		43 days
Secondary	PK Parameter: The ratio of total radioactivity in whole blood to that in plasma following oral administration of a single dose of [14C] BIIB122 ([14C]-DNL151)		43 days
Secondary	Chemical identities of the [14C] metabolites of [14C] BIIB122 ([14C]-DNL151) measured in plasma, urine, and feces		43 days