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

Sponsor
Biogen (Industry)
Overall Status
Completed
CT.gov ID
NCT05119790
Collaborator
Denali Therapeutics Inc. (Industry)
7
1
1
2.3
3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: [14C] BIIB122 ([14C] DNL151)
Phase 1

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.).

Study Design

Study Type:
Interventional
Actual Enrollment :
7 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Aug 27, 2021
Actual Primary Completion Date :
Nov 5, 2021
Actual Study Completion Date :
Nov 5, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort A

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

Outcome Measures

Primary Outcome Measures

  1. Mass balance (total recovery) following oral administration of a single dose of [14C] BIIB122 ([14C]-DNL151) [43 days]

  2. Percentage of radioactivity recovered in urine following oral administration of a single dose of [14C] BIIB122 ([14C]-DNL151) [43 days]

  3. Percentage of radioactivity recovered in feces following oral administration of a single dose of [14C] BIIB122 ([14C]-DNL151) [43 days]

  4. 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]

  5. 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]

  6. 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]

  7. 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]

  8. 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]

  9. 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]

  10. 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 Outcome Measures

  1. Incidence of adverse events (AEs) [43 days]

  2. 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]

  3. Chemical identities of the [14C] metabolites of [14C] BIIB122 ([14C]-DNL151) measured in plasma, urine, and feces [43 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pharmaron CPC Baltimore Maryland United States 21201

Sponsors and Collaborators

  • Biogen
  • Denali Therapeutics Inc.

Investigators

  • Study Director: Medical Director, Denali Therapeutics Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Biogen
ClinicalTrials.gov Identifier:
NCT05119790
Other Study ID Numbers:
  • 283HV102
First Posted:
Nov 15, 2021
Last Update Posted:
Dec 7, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Dec 7, 2021