Healthy Volunteers
Conditions
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.
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.).
Interventions
Oral dose
Sponsors
Denali Therapeutics Inc.
Biogen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Incidence of adverse events (AEs) | 43 days |
Countries
United States
Outcome results
None listed