Clinical trial NCT05005338: A Study to Determine the Absolute Bioavailability of BIIB122/DNL151 in Healthy Subjects
Official title: An Open Label Phase 1 Study to Determine the Absolute Bioavailability of Single and Repeated Daily Oral Administration of BIIB122 (DNL151) Utilizing a Microtracer Dose of Intravenously Administered [14C] BIIB122 ([14C] DNL151) to Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Biogen
Sponsor class: INDUSTRY
Collaborators: name: Denali Therapeutics Inc.
First posted: 2021-08-13
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single center, non-randomized, open label Phase 1 study to determine the PK and absolute bioavailability of BIIB122 (DNL151) in 2 conditions: following a single, oral dose of BIIB122 (DNL151) and following consecutive days of oral dosing, approximating steady state.

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.).

Eligibility criteria: Key Inclusion Criteria:

* Women of non-childbearing potential and men either with a vasectomy, using contraception, or having sex with a woman of non-childbearing potential
* Body mass index (BMI) ≥ 18 kg/m2 and ≤ 32 kg/m2
* Considered to be in good health
* Nonsmoker

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

Primary outcomes:
measure: PK Parameter: The first time to maximum observed concentration (Tmax) of BIIB122 (DNL151) in plasma following oral administration
timeFrame: 1 day
measure: PK Parameter: Maximum observed concentration (Cmax) of BIIB122 (DNL151) in plasma following oral administration
timeFrame: 1 day
measure: PK Parameter: Area under the concentration-time curve (AUC) of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151 in plasma following oral and intravenous administration
timeFrame: 1 day
measure: PK Parameter: Time from baseline at which half of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151 has been eliminated (t1/2) in plasma after oral and intravenous administration
timeFrame: 1 day
measure: PK Parameter: Clearance (CL/F and CL) of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151) from plasma after oral and intravenous administration
timeFrame: 1 day
measure: PK Parameter: Volume of distribution (Vd/F and Vd) of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151) from plasma after oral and intravenous administration
timeFrame: 1 day
measure: PK Parameter: Absolute bioavailability (F) of BIIB122 (DNL151) after oral administration
timeFrame: 1 day
measure: PK Parameter: The first time to maximum observed concentration (Tmax) of BIIB122 (DNL151) in plasma following oral administration
timeFrame: 21 days
measure: PK Parameter: Maximum observed concentration (Cmax) of BIIB122 (DNL151) in plasma following oral administration
timeFrame: 21 days
measure: PK Parameter: Concentration of BIIB122 (DNL151) in plasma at the end of dosing interval
timeFrame: 21 days
measure: PK Parameter: Area under the concentration-time curve of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151) in plasma following oral and intravenous administration
timeFrame: 21 days
measure: PK Parameter: Time from baseline at which half of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151) has been eliminated (t1/2) in plasma after oral and intravenous administration
timeFrame: 21 days
measure: PK Parameter: Volume of distribution (Vd/F and Vd) of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151) from plasma after oral and intravenous administration
timeFrame: 21 days
measure: PK Parameter: Clearance (CL/F and CL) of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151) from plasma after oral and intravenous administration
timeFrame: 21 days
measure: PK Parameter: Absolute bioavailability (F) of BIIB122 (DNL151) after oral administration
timeFrame: 21 days
Secondary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: 31 days
measure: Incidence of serious adverse events (SAEs)
timeFrame: 31 days
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Pharmaron CPC
state: Maryland
Study officials:
affiliation: Denali Therapeutics Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: