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

NCT03943056 | Completed Phase 1 FDA Drug

• 1 other identifier: 257HV101
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

  An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose: results in death, in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event), however, this does not include an event that, had it occurred in a more severe form, might have caused death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect or is a medically important event.

  Baseline up to Day 9 for SAD Cohorts; Baseline up to Day 24 for MAD Cohorts

Secondary Outcomes (13)

• Area Under the Curve from Time 0 to the Time of the Last Measurable Concentration (AUClast)

  Baseline and multiple timepoints up to Day 3 for SAD Cohorts; Baseline and multiple timepoints up to Day 16 for MAD Cohorts

• Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf)

  Baseline and multiple timepoints up to Day 3

• Maximum Observed Concentration (Cmax)

  Baseline and multiple timepoints up to Day 3 for SAD Cohorts; Baseline and multiple timepoints up to Day 14 for MAD Cohorts

• Time to Reach Maximum Observed Concentration (Tmax)

  Baseline and multiple timepoints up to Day 3 for SAD Cohorts; Baseline and multiple timepoints up to Day 14 for MAD Cohorts

• Elimination Half-Life (t½)

  Baseline and multiple timepoints up to Day 3 for SAD Cohorts; Baseline and multiple timepoints up to Day 16 for MAD Cohorts

Study Arms (8)

Single Ascending Dose (SAD): Cohort 1A

EXPERIMENTAL

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

Drug: BIIB091; Drug: Placebo

(SAD): Cohort 2A

EXPERIMENTAL

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

Drug: BIIB091; Drug: Placebo

(SAD): Cohort 3A

EXPERIMENTAL

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.

Drug: BIIB091; Drug: Placebo

(SAD): Cohort 4A

EXPERIMENTAL

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

Drug: BIIB091; Drug: Placebo

(SAD): Cohort 5A

EXPERIMENTAL

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

Drug: BIIB091; Drug: Placebo

Multiple Ascending Dose (MAD): Cohort 1B

EXPERIMENTAL

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

Drug: BIIB091; Drug: Placebo

(MAD): Cohort 2B

EXPERIMENTAL

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

Drug: BIIB091; Drug: Placebo

(MAD): Cohort 3B

EXPERIMENTAL

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

Drug: BIIB091; Drug: Placebo

Interventions

BIIB091 DRUG

Administered as specified in the treatment arm.

(MAD): Cohort 2B; (MAD): Cohort 3B; (SAD): Cohort 2A; (SAD): Cohort 3A; (SAD): Cohort 4A; (SAD): Cohort 5A; Multiple Ascending Dose (MAD): Cohort 1B; Single Ascending Dose (SAD): Cohort 1A

Placebo DRUG

Administered as specified in the treatment arm.

(MAD): Cohort 2B; (MAD): Cohort 3B; (SAD): Cohort 2A; (SAD): Cohort 3A; (SAD): Cohort 4A; (SAD): Cohort 5A; Multiple Ascending Dose (MAD): Cohort 1B; Single Ascending Dose (SAD): Cohort 1A

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Research Site

Dallas, Texas, 75247, United States

Location

MeSH Terms

Interventions

BIIB091

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinded Study
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 9, 2019
• Study Start: May 13, 2019
• Primary Completion: January 10, 2020
• Study Completion: January 10, 2020
• Last Updated: March 22, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)