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

Biogen

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: Placebo; Drug: BIIB091

Study type: Interventional

Funder types: Industry

Identifiers

NCT03943056

257HV101

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Key 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.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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64 participants in 8 patient groups

Single Ascending Dose (SAD): Cohort 1A

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: BIIB091

(SAD): Cohort 2A

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: BIIB091

(SAD): Cohort 3A

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: BIIB091

(SAD): Cohort 4A

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: BIIB091

(SAD): Cohort 5A

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: BIIB091

Multiple Ascending Dose (MAD): Cohort 1B

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: BIIB091

(MAD): Cohort 2B

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: BIIB091

(MAD): Cohort 3B

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: BIIB091