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A Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of BIIB091, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Healthy Adult Participants

NCT ID: NCT03943056

Last Updated: 2021-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-13

Study Completion Date

2020-01-10

Brief Summary

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This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of BIIB091 in healthy participants.This study will also determine the effect of food on the single oral dose pharmacokinetic (PK).

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Detailed Description

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Initial protocol recruitment and follow up was completed by 10 Jan 2020 with an optional cohort intended for completion by April 2020. Subsequently, a decision was made not to progress this optional cohort in light of COVID-19 which has resulted in a delay in reporting the actual completion date.

Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Blinded Study

Study Groups

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Single Ascending Dose (SAD): Cohort 1A

Participants will receive dose level 1 of BIIB091 or placebo, orally, while fasting on Day 1.

Group Type EXPERIMENTAL

BIIB091

Intervention Type DRUG

Administered as specified in the treatment arm.

Placebo

Intervention Type DRUG

Administered as specified in the treatment arm.

(SAD): Cohort 2A

Participants will receive dose level 2 of BIIB091 or placebo, orally, while fasting on Day 1.

Group Type EXPERIMENTAL

BIIB091

Intervention Type DRUG

Administered as specified in the treatment arm.

Placebo

Intervention Type DRUG

Administered as specified in the treatment arm.

(SAD): Cohort 3A

Participants will receive dose level 3 of BIIB091 or placebo, orally, while fasting on Day 1, then again following a 7 day washout and high-fat meal.

Group Type EXPERIMENTAL

BIIB091

Intervention Type DRUG

Administered as specified in the treatment arm.

Placebo

Intervention Type DRUG

Administered as specified in the treatment arm.

(SAD): Cohort 4A

Participants will receive dose level 4 of BIIB091 or placebo, orally, while fasting on Day 1.

Group Type EXPERIMENTAL

BIIB091

Intervention Type DRUG

Administered as specified in the treatment arm.

Placebo

Intervention Type DRUG

Administered as specified in the treatment arm.

(SAD): Cohort 5A

Participants will receive dose level 5 of BIIB091 or placebo, orally, while fasting on Day 1.

Group Type EXPERIMENTAL

BIIB091

Intervention Type DRUG

Administered as specified in the treatment arm.

Placebo

Intervention Type DRUG

Administered as specified in the treatment arm.

Multiple Ascending Dose (MAD): Cohort 1B

Participants will receive dose level 1 of BIIB091 or placebo, orally, twice daily (BID) for 13 days, and a single dose on Day 14.

Group Type EXPERIMENTAL

BIIB091

Intervention Type DRUG

Administered as specified in the treatment arm.

Placebo

Intervention Type DRUG

Administered as specified in the treatment arm.

(MAD): Cohort 2B

Participants will receive dose level 2 of BIIB091 or placebo, orally, BID for 13 days, and a single dose on Day 14.

Group Type EXPERIMENTAL

BIIB091

Intervention Type DRUG

Administered as specified in the treatment arm.

Placebo

Intervention Type DRUG

Administered as specified in the treatment arm.

(MAD): Cohort 3B

Participants will receive dose level 3 of BIIB091 or placebo, orally, BID for 13 days, and a single dose on Day 14.

Group Type EXPERIMENTAL

BIIB091

Intervention Type DRUG

Administered as specified in the treatment arm.

Placebo

Intervention Type DRUG

Administered as specified in the treatment arm.

Interventions

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BIIB091

Administered as specified in the treatment arm.

Intervention Type DRUG

Placebo

Administered as specified in the treatment arm.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with applicable participant privacy regulations.
* Have a body mass index between 18 and 30 kg/m2, inclusive.
* All male participants must practice highly effective methods of contraception and not donate sperm during the study and for at least 1 spermatogenic cycle (90 days) after administration of last dose of study treatment.
* All female participants of childbearing potential must practice highly effective methods of contraception and not donate eggs during the study and for at least 90 days after their last dose of study treatment.
* Must be in good health as by the Investigator, based on medical history and screening evaluations.

Exclusion Criteria

* History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic,hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
* History of severe allergic or anaphylactic reactions, or of any allergic reactions that in the opinion of the Investigator are likely to be exacerbated by any component of the study treatment.
* History of, or ongoing, malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell carcinomas and squamous cell carcinomas that have been completely excised and considered cured at least 12 months prior to Check-in).
* Current enrollment or plan to enroll in any other drug, biological, device, or clinical study, or treatment with an investigational drug or approved therapy for investigational use within 30 days prior to Check-in, or 5 half-lives of the drug or therapy, whichever is longer.
* Breastfeeding, pregnant, or planning to become pregnant during study participation.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

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Research Site

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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257HV101

Identifier Type: -

Identifier Source: org_study_id

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