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Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB061 in Healthy Adult Volunteers Including Absolute Bioavailability and Food Effect

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02071121
First Posted: February 25, 2014
Last Update Posted: February 2, 2015
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. Read our disclaimer for details.
Information provided by (Responsible Party):
Biogen
  Purpose
The primary objective of this study is to evaluate the safety and tolerability of single doses of BIIB061 administered to healthy adult volunteers. Secondary objectives in this study population are to determine the single-dose pharmacokinetic (PK) profile and the absolute bioavailability (Fabs) of BIIB061 and to determine the effects of food intake (high-fat, high-calorie meal) on BIIB061 PK and safety.

Condition Intervention Phase
Healthy Drug: BIIB061 Drug: Placebo Drug: 14C-BIIB061 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blinded, Placebo-Controlled, Single-Ascending-Dose (SAD) Study of the Safety, Tolerability, and Pharmacokinetics of BIIB061 in Healthy Adult Volunteers Including Absolute Bioavailability and Food Effect

Further study details as provided by Biogen:

Primary Outcome Measures:
  • Number of participants that experience adverse events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 28 days ]

Secondary Outcome Measures:
  • Area under the concentration-time curve from time 0 to infinity (AUCinf) of BIIB061 [ Time Frame: Predose and up to 28 days post-dose. ]
  • Maximum observed concentration (Cmax) of BIIB061 [ Time Frame: Predose and up to 28 days post-dose. ]
  • Time to reach maximum observed concentration (Tmax) of BIIB061 [ Time Frame: Predose and up to 28 days post-dose. ]
  • Half-life (t1/2) of BIIB061 [ Time Frame: Predose and up to 28 days post-dose. ]
  • Absolute bioavailability (Fabs) of BIIB061 for the absolute bioavailability cohort only [ Time Frame: Predose and up to 28 days post-dose. ]
  • Clearance of BIIB061 for the absolute bioavailability cohort only. [ Time Frame: Predose and up to 28 days post-dose. ]
  • Volume of distribution (Vd) of BIIB061 for the absolute bioavailability cohort only. [ Time Frame: Predose and up to 28 days post-dose. ]
  • The difference between PK parameters (AUC, Cmax, Tmax, and t1/2) taken under fasting conditions and following a high-fat, high-calorie meal are analyzed [ Time Frame: Day 1 to Week 4 (28-day fasting PK measurements), a washout period followed by dosing after a high-fat, high-calorie meal (28-day PK measurements) ]
    For the fasting PK portion of the study, participants' PK samples are taken after an overnight fast of at least 10 hours. For the food effect portion of the study, the dose is given 30 minutes following a high-fat, high-calorie meal.


Enrollment: 39
Study Start Date: December 2013
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Fasted participants will receive a single oral dose of placebo to BIIB061.
Drug: Placebo
BIIB061 matching placebo capsules
Experimental: BIIB061 3 mg
Fasted participants will receive a single oral dose of BIIB061 3 mg.
Drug: BIIB061
BIIB061 capsules for oral administration
Experimental: BIIB061 10 mg
Fasted participants will receive a single oral dose of BIIB061 10 mg followed by a tracer amount of 14C-BIIB061 (at ≤ 500 nCi/participant; approximately 4 μg of BIIB061), administered by manual slow intravenous push injection at 4 hours postdose.
Drug: BIIB061
BIIB061 capsules for oral administration
Drug: 14C-BIIB061
Radiolabeled containing 14C-BIIB061 ≤ 500 nCi.
Experimental: BIIB061 30 mg
Fasted participants will receive a single oral dose of BIIB061 30 mg. Following a washout period, participants will receive the same dose of BIIB061 after a high-fat, high-calorie meal (fed state).
Drug: BIIB061
BIIB061 capsules for oral administration
Experimental: BIIB061 60 mg
Fasted participants will receive a single oral dose of BIIB061 60 mg.
Drug: BIIB061
BIIB061 capsules for oral administration
Experimental: BIIB061 100 mg
Fasted participants will receive a single oral dose of BIIB061 100 mg.
Drug: BIIB061
BIIB061 capsules for oral administration

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  • Males and postmenopausal (defined as no menses for 12 months and confirmed by follicle-stimulating hormone (FSH) levels determined at screening to be in the postmenopausal range) or surgically sterile females.
  • All males must practice effective contraception during the study and be willing and able to continue male contraception for 3 months after the dose of study treatment. All male participants must also be willing to refrain from sperm donation for at least 3 months after their last dose of study treatment. Note: Females of childbearing potential, are not allowed to enter the study.
  • Must be in good health and have normal vital signs as determined by the Investigator.
  • Participants agree to abstain from alcohol ingestion for the duration of time that they are in the study.
  • Must be a nonsmoker and must not use chewing tobacco or nicotine products, for at least 3 months prior to Day -1.
  • Must have a body mass index (BMI) of 18 to 30 kg/m2, inclusive.

Key Exclusion Criteria:

  • History of or positive test result at screening for human immunodeficiency virus (HIV).
  • History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, oncologic, or other major disease, as determined by the Investigator.
  • Clinically significant (as determined by the Investigator) 12-lead electrocardiogram (ECG) abnormalities, including corrected QT interval using Fridericia's correction method of >450 ms for males and >470 ms for females.
  • History of severe allergic or anaphylactic reactions.
  • Serious infection (e.g., pneumonia, septicemia) as determined by the Investigator, within 3 months prior to Day -1.
  • Consumption of grapefruit or grapefruit-containing products within 3 days of dosing.
  • Treatment with any over-the-counter products, including herbal and/or alternative health preparations and procedures within the 14 days prior to Day -1.
  • Current enrollment in any other drug, biologic, device, or clinical study, or treatment with an investigational drug or approved therapy for investigational use within 30 days (or 5 half-lives, whichever is longer) prior to Day -1.
  • Blood donation (1 unit or more) within 30 days prior to Day -1
  • History of drug or alcohol abuse (as determined by the Investigator), a positive urine drug/alcohol test, or a positive cotinine test at Screening or Day -1, or alcohol use within 48 hours (as reported by the subject) prior to Day -1.
  • Vigorous exercise (as determined by the Investigator) within 48 hours prior to Day -1.
  • History of malignant disease, including solid tumors and hematologic malignancies.
  • Surgery within 3 months prior to Day-1.
  • History of seizures other than childhood febrile seizure.
  • Inability or unwillingness to comply with study requirements.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02071121


Locations
United States, Indiana
Research Site
Evansville, Indiana, United States, 47710
United States, Wisconsin
Research Site
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen
  More Information

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02071121     History of Changes
Other Study ID Numbers: 231HV101
First Submitted: February 21, 2014
First Posted: February 25, 2014
Last Update Posted: February 2, 2015
Last Verified: October 2014

Keywords provided by Biogen:
BIIB061
Healthy