A Study of Mass Balance, Pharmacokinetics, Metabolite Profile, and Metabolite Identification of BIIB122/DNL151 in Healthy Male Subjects
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 |
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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
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Cohort A
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Drug: [14C] BIIB122 ([14C] DNL151)
Oral dose
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Outcome Measures
Primary Outcome Measures
- Mass balance (total recovery) following oral administration of a single dose of [14C] BIIB122 ([14C]-DNL151) [43 days]
- Percentage of radioactivity recovered in urine following oral administration of a single dose of [14C] BIIB122 ([14C]-DNL151) [43 days]
- Percentage of radioactivity recovered in feces following oral administration of a single dose of [14C] BIIB122 ([14C]-DNL151) [43 days]
- 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]
- 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]
- 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]
- 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]
- 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]
- 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]
- 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
- Incidence of adverse events (AEs) [43 days]
- 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]
- Chemical identities of the [14C] metabolites of [14C] BIIB122 ([14C]-DNL151) measured in plasma, urine, and feces [43 days]
Eligibility Criteria
Criteria
key Inclusion Criteria:
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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
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Body mass index ≥18.0 kg/m2 and ≤32.0 kg/m2
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Body weight ≥5.0 kg and ≤100.0 kg
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Considered to be in good health
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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 | |
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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.- 283HV102