NCT05119790

Brief Summary

This is a single-center, non-randomized, open-label Phase 1 study to determine the absorption, metabolism, and excretion (AME) of BIIB122 (DNL151) following administration of a single oral dose of \[14C\] BIIB122 (\[14C\] DNL151) following a fast. The mass balance, excretion, and PK of BIIB122 (DNL151) will be used to evaluate AME.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started Aug 2021

Shorter than P25 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

August 27, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 15, 2021

Completed
Last Updated

December 7, 2021

Status Verified

November 1, 2021

Enrollment Period

2 months

First QC Date

August 27, 2021

Last Update Submit

November 30, 2021

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (10)

  • Mass balance (total recovery) following oral administration of a single dose of [14C] BIIB122 ([14C]-DNL151)

    43 days

  • Percentage of radioactivity recovered in urine following oral administration of a single dose of [14C] BIIB122 ([14C]-DNL151)

    43 days

  • Percentage of radioactivity recovered in feces following oral administration of a single dose of [14C] BIIB122 ([14C]-DNL151)

    43 days

  • PK Parameter: The first time to maximum observed concentration (Tmax) for total radioactivity and BIIB122 (DNL151) in blood following oral administration of a single dose of [14C]-BIIB122 ([14C]-DNL151)

    43 days

  • PK Parameter: Maximum observed plasma concentration (Cmax) occurring at Tmax for total radioactivity and BIIB122 (DNL151) in blood following oral administration of a single dose of [14C]-BIIB122 ([14C]-DNL151)

    43 days

  • PK Parameter: Area under the concentration-time curve (AUC) of total radioactivity and BIIB122 (DNL151) in blood following oral administration of a single dose of [14C]-BIIB122 ([14C]-DNL151)

    43 days

  • PK Parameter: Time at which half the drug has been eliminated (T1/2) of total radioactivity and BIIB122 (DNL151) in blood following oral administration of a single dose of [14C]-BIIB122 ([14C]-DNL151)

    43 days

  • PK Parameter: Apparent systemic clearance (CL/F) of total radioactivity and BIIB122 (DNL151) in blood following oral administration of a single dose of [14C] BIIB122 ([14C]-DNL151)

    43 days

  • PK Parameter: Apparent volume of distribution (Vz/F) of total reactivity and BIIB122 (DNL151) in blood following oral administration of a single dose of [14C] BIIB122 ([14C]-DNL151)

    43 days

  • Profiles of [14C] BIIB122 ([14C]-DNL151) and its [14C] metabolites in plasma, urine, and feces following oral administration of a single dose of [14C] BIIB122 ([14C]-DNL151)

    43 days

Secondary Outcomes (3)

  • Incidence of adverse events (AEs)

    43 days

  • PK Parameter: The ratio of total radioactivity in whole blood to that in plasma following oral administration of a single dose of [14C] BIIB122 ([14C]-DNL151)

    43 days

  • Chemical identities of the [14C] metabolites of [14C] BIIB122 ([14C]-DNL151) measured in plasma, urine, and feces

    43 days

Study Arms (1)

Cohort A

EXPERIMENTAL
Drug: [14C] BIIB122 ([14C] DNL151)

Interventions

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

Oral dose

Cohort A

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • For men who choose to have sex with women, either: vasectomy, use of condoms, or sex with a woman who is of non-childbearing potential
  • Body mass index ≥18.0 kg/m2 and ≤32.0 kg/m2
  • Body weight ≥5.0 kg and ≤100.0 kg
  • Considered to be in good health
  • Non-smoker

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pharmaron CPC

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Interventions

DNL151

Study Officials

  • Medical Director

    Denali Therapeutics Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2021

First Posted

November 15, 2021

Study Start

August 27, 2021

Primary Completion

November 5, 2021

Study Completion

November 5, 2021

Last Updated

December 7, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)