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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03943056
Recruitment Status : Recruiting
First Posted : May 9, 2019
Last Update Posted : January 21, 2020
Sponsor:
Information provided by (Responsible Party):
Biogen

Tracking Information
First Submitted Date  ICMJE May 7, 2019
First Posted Date  ICMJE May 9, 2019
Last Update Posted Date January 21, 2020
Actual Study Start Date  ICMJE May 13, 2019
Estimated Primary Completion Date April 13, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2019)
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Day 9 for SAD Cohorts; Baseline up to Day 24 for MAD Cohorts ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2019)
  • 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 ]
  • Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf) [ Time Frame: Baseline and multiple timepoints up to Day 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Amount of BIIB091 Excreted in Urine per Sampling Interval (Aeu) [ Time Frame: Baseline and multiple timepoints up to Day 3 ]
  • Percentage of BIIB091 Excreted in Urine per Sampling Interval (%Feu) [ Time Frame: Baseline and multiple timepoints up to Day 3 ]
  • Renal clearance (CLr) [ Time Frame: Baseline and multiple timepoints up to Day 3 ]
  • Area Under the Concentration-Time Curve Within a Dosing Interval (AUCtau) [ Time Frame: Baseline and multiple timepoints up to Day 16 ]
  • Accumulation Ratio (R) [ Time Frame: Baseline and multiple timepoints up to Day 16 ]
  • Trough concentration (Ctrough) [ Time Frame: Baseline and multiple timepoints up to Day 16 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of BIIB091, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Healthy Adult Participants
Official Title  ICMJE A Phase 1, Randomized, Blinded, Placebo-Controlled, Single- and Multiple-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of BIIB091, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Healthy Adult Participants
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Blinded Study
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteer
Intervention  ICMJE
  • Drug: BIIB091
    Administered as specified in the treatment arm.
  • Drug: Placebo
    Administered as specified in the treatment arm.
Study Arms  ICMJE
  • Experimental: Single Ascending Dose (SAD): Cohort 1A
    Participants will receive dose level 1 of BIIB091 or placebo, orally, while fasting on Day 1.
    Interventions:
    • Drug: BIIB091
    • Drug: Placebo
  • Experimental: (SAD): Cohort 2A
    Participants will receive dose level 2 of BIIB091 or placebo, orally, while fasting on Day 1.
    Interventions:
    • 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.
    Interventions:
    • Drug: BIIB091
    • Drug: Placebo
  • Experimental: (SAD): Cohort 4A
    Participants will receive dose level 4 of BIIB091 or placebo, orally, while fasting on Day 1.
    Interventions:
    • Drug: BIIB091
    • Drug: Placebo
  • Experimental: (SAD): Cohort 5A
    Participants will receive dose level 5 of BIIB091 or placebo, orally, while fasting on Day 1.
    Interventions:
    • 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.
    Interventions:
    • 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.
    Interventions:
    • 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.
    Interventions:
    • Drug: BIIB091
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 7, 2019)
64
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 13, 2020
Estimated Primary Completion Date April 13, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: US Biogen Clinical Trial Center 866-633-4636 clinicaltrials@biogen.com
Contact: Global Biogen Clinical Trial Center clinicaltrials@biogen.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03943056
Other Study ID Numbers  ICMJE 257HV101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/
URL: http://www.biogenclinicaldatarequest.com
Responsible Party Biogen
Study Sponsor  ICMJE Biogen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Biogen
PRS Account Biogen
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP