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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05005338
• Other study ID #: 283HV103
• Status: Completed
• Phase: Phase 1
• Start date: July 28, 2021
• Est. completion date: September 23, 2021

Study information

• Verified date: November 2021
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: September 23, 2021
• Est. primary completion date: September 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• BIIB122 (DNL151)
Oral doses
• [14C] BIIB122 ([14C] DNL151)
Intravenous doses

Locations

Country	Name	City	State
United States	Pharmaron CPC	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Biogen	Denali Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK Parameter: The first time to maximum observed concentration (Tmax) of BIIB122 (DNL151) in plasma following oral administration		1 day
Primary	PK Parameter: Maximum observed concentration (Cmax) of BIIB122 (DNL151) in plasma following oral administration		1 day
Primary	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
Primary	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
Primary	PK Parameter: Clearance (CL/F and CL) of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151) from plasma after oral and intravenous administration		1 day
Primary	PK Parameter: Volume of distribution (Vd/F and Vd) of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151) from plasma after oral and intravenous administration		1 day
Primary	PK Parameter: Absolute bioavailability (F) of BIIB122 (DNL151) after oral administration		1 day
Primary	PK Parameter: The first time to maximum observed concentration (Tmax) of BIIB122 (DNL151) in plasma following oral administration		21 days
Primary	PK Parameter: Maximum observed concentration (Cmax) of BIIB122 (DNL151) in plasma following oral administration		21 days
Primary	PK Parameter: Concentration of BIIB122 (DNL151) in plasma at the end of dosing interval		21 days
Primary	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
Primary	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
Primary	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
Primary	PK Parameter: Clearance (CL/F and CL) of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151) from plasma after oral and intravenous administration		21 days
Primary	PK Parameter: Absolute bioavailability (F) of BIIB122 (DNL151) after oral administration		21 days
Secondary	Incidence of adverse events (AEs)		31 days
Secondary	Incidence of serious adverse events (SAEs)		31 days