NCT05005338

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started Jul 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

July 27, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

July 28, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 13, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2021

Completed
Last Updated

November 17, 2021

Status Verified

November 1, 2021

Enrollment Period

2 months

First QC Date

July 27, 2021

Last Update Submit

November 9, 2021

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (15)

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

    1 day

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

    1 day

  • 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: 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: Clearance (CL/F and CL) of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151) from plasma after 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

    1 day

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

    1 day

  • 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: Concentration of BIIB122 (DNL151) in plasma at the end of dosing interval

    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: 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: 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: 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 Outcomes (2)

  • Incidence of adverse events (AEs)

    31 days

  • Incidence of serious adverse events (SAEs)

    31 days

Study Arms (1)

Cohort A

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

Interventions

BIIB122 (DNL151)DRUG

Oral doses

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

Intravenous doses

Cohort A

Eligibility Criteria

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

You may qualify if:

  • 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

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

July 27, 2021

First Posted

August 13, 2021

Study Start

July 28, 2021

Primary Completion

September 23, 2021

Study Completion

September 23, 2021

Last Updated

November 17, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)