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

Sponsor
Biogen (Industry)
Overall Status
Completed
CT.gov ID
NCT05005338
Collaborator
Denali Therapeutics Inc. (Industry)
8
Enrollment
1
Location
1
Arm
1.9
Actual Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: BIIB122 (DNL151)
  • Drug: [14C] BIIB122 ([14C] DNL151)
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

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jul 28, 2021
Actual Primary Completion Date :
Sep 23, 2021
Actual Study Completion Date :
Sep 23, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: Cohort A

Drug: BIIB122 (DNL151)
Oral doses

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

Outcome Measures

Primary Outcome Measures

  1. PK Parameter: The first time to maximum observed concentration (Tmax) of BIIB122 (DNL151) in plasma following oral administration [1 day]

  2. PK Parameter: Maximum observed concentration (Cmax) of BIIB122 (DNL151) in plasma following oral administration [1 day]

  3. 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]

  4. 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]

  5. PK Parameter: Clearance (CL/F and CL) of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151) from plasma after oral and intravenous administration [1 day]

  6. 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]

  7. PK Parameter: Absolute bioavailability (F) of BIIB122 (DNL151) after oral administration [1 day]

  8. PK Parameter: The first time to maximum observed concentration (Tmax) of BIIB122 (DNL151) in plasma following oral administration [21 days]

  9. PK Parameter: Maximum observed concentration (Cmax) of BIIB122 (DNL151) in plasma following oral administration [21 days]

  10. PK Parameter: Concentration of BIIB122 (DNL151) in plasma at the end of dosing interval [21 days]

  11. 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]

  12. 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]

  13. 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]

  14. PK Parameter: Clearance (CL/F and CL) of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151) from plasma after oral and intravenous administration [21 days]

  15. PK Parameter: Absolute bioavailability (F) of BIIB122 (DNL151) after oral administration [21 days]

Secondary Outcome Measures

  1. Incidence of adverse events (AEs) [31 days]

  2. Incidence of serious adverse events (SAEs) [31 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Pharmaron CPCBaltimoreMarylandUnited States21201

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.
Responsible Party:
Biogen
ClinicalTrials.gov Identifier:
NCT05005338
Other Study ID Numbers:
  • 283HV103
First Posted:
Aug 13, 2021
Last Update Posted:
Nov 17, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 17, 2021