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Completed

NCT Number: NCT05005338

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pharmaron CPC

Baltimore, Maryland, 21201, United States

About this study

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.).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BIIB122 (DNL151)

Drug

Oral doses

[14C] BIIB122 ([14C] DNL151)

Drug

Intravenous doses

Primary outcomes

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

    Time frame: 1 day

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 1 day

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

    Time frame: 1 day

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

    Time frame: 21 days

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

    Time frame: 21 days

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 21 days

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

    Time frame: 21 days

Secondary outcomes

  1. Incidence of adverse events (AEs)

    Time frame: 31 days

  2. Incidence of serious adverse events (SAEs)

    Time frame: 31 days

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Collaborators

  • Denali Therapeutics Inc.

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 13, 2021
Registry last updated
Nov 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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