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CompletedNCT03943056Updated Mar 22, 2021

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

A Phase 1 interventional study of BIIB091 and Placebo in Healthy Volunteer, sponsored by Biogen. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-22.

Sponsored by Biogen · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Jan 2020, 6 years 8 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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).

Read the detailed 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.

02

Conditions studied

  • Healthy Volunteer
03

In context

Lead sponsor

Biogen is the lead sponsor of 494 studies on the registry; 22 are open to participants now.

Of its 98 completed or terminated interventional studies of FDA-regulated products, 49 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility 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.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    Single Ascending Dose (SAD): Cohort 1A

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

    Drug: BIIB091 · Drug: Placebo

  • Experimental
    (SAD): Cohort 2A

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

    Drug: BIIB091 · Drug: Placebo

  • Experimental
    (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.

    Drug: BIIB091 · Drug: Placebo

  • Experimental
    (SAD): Cohort 4A

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

    Drug: BIIB091 · Drug: Placebo

  • Experimental
    (SAD): Cohort 5A

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

    Drug: BIIB091 · Drug: Placebo

  • Experimental
    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.

    Drug: BIIB091 · Drug: Placebo

  • Experimental
    (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.

    Drug: BIIB091 · Drug: Placebo

  • Experimental
    (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.

    Drug: BIIB091 · Drug: Placebo

Interventions

  • DrugBIIB091

    Administered as specified in the treatment arm.

  • DrugPlacebo

    Administered as specified in the treatment arm.

06

What researchers measure

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.

    Time frame: Baseline up to Day 9 for SAD Cohorts; Baseline up to Day 24 for MAD Cohorts

Secondary outcomes

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

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

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

    Time frame: Baseline and multiple timepoints up to Day 3

  3. Maximum Observed Concentration (Cmax)

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

  4. Time to Reach Maximum Observed Concentration (Tmax)

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

  5. Elimination Half-Life (t½)

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

  6. Apparent Total Body Clearance (CL/F)

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

  7. Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F)

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

  8. Amount of BIIB091 Excreted in Urine per Sampling Interval (Aeu)

    Time frame: Baseline and multiple timepoints up to Day 3

  9. Percentage of BIIB091 Excreted in Urine per Sampling Interval (%Feu)

    Time frame: Baseline and multiple timepoints up to Day 3

  10. Renal clearance (CLr)

    Time frame: Baseline and multiple timepoints up to Day 3

  11. Area Under the Concentration-Time Curve Within a Dosing Interval (AUCtau)

    Time frame: Baseline and multiple timepoints up to Day 16

  12. Accumulation Ratio (R)

    Time frame: Baseline and multiple timepoints up to Day 16

  13. Trough concentration (Ctrough)

    Time frame: Baseline and multiple timepoints up to Day 16

07

Study locations

1 site
  • Research Site
    Dallas, Texas 75247, United States
08

References and documents

Individual participant data

Plan to share: Yes — In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03943056
Lead sponsor
Biogen
Responsible party
Sponsor
First posted
May 9, 2019
Start date
May 13, 2019
Primary completion
Jan 10, 2020
Completion
Jan 10, 2020
Last update
Mar 22, 2021

Study contacts

Medical Director
study director · Biogen

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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