A Study to Determine the Absolute Bioavailability of BIIB122/DNL151 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: BIIB122 (DNL151); Drug: [14C] BIIB122 ([14C] DNL151)

• Registration Number: NCT05005338
• Lead Sponsor: Biogen

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.).

Study Timeline

• Study First Submitted: 2021-07-27
• Study Start: 2021-07-28
• Study First Submitted QC: 2021-08-09
• Study First Posted: 2021-08-13
• Primary Completion: 2021-09-23
• Study Completion: 2021-09-23
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-09
• Last Update Posted: 2021-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort A	[14C] BIIB122 ([14C] DNL151)	-
Cohort A	BIIB122 (DNL151)	-

Primary Outcome Measures

Name	Time	Method
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	1 day
PK Parameter: Concentration of BIIB122 (DNL151) in plasma at the end of dosing interval	21 days
PK Parameter: The first time to maximum observed concentration (Tmax) of BIIB122 (DNL151) in plasma following oral administration	21 days
PK Parameter: Maximum observed concentration (Cmax) of BIIB122 (DNL151) in plasma following oral administration	21 days
PK Parameter: Area under the concentration-time curve (AUC) of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151 in plasma following oral and intravenous administration	1 day
PK Parameter: Volume of distribution (Vd/F and Vd) of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151) from plasma after oral and intravenous administration	21 days
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	21 days
PK Parameter: Area under the concentration-time curve of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151) in plasma following oral and intravenous administration	21 days
PK Parameter: Clearance (CL/F and CL) of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151) from plasma after oral and intravenous administration	21 days
PK Parameter: Absolute bioavailability (F) of BIIB122 (DNL151) after oral administration	21 days

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events (AEs)	31 days
Incidence of serious adverse events (SAEs)	31 days

Trial Locations

Locations (1)

Pharmaron CPC; 🇺🇸 Baltimore, Maryland, United States