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

NCT ID: NCT02071121

Last Updated: 2015-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2014-09-30

Brief Summary

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Fasted participants will receive a single oral dose of placebo to BIIB061.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

BIIB061 matching placebo capsules

BIIB061 3 mg

Fasted participants will receive a single oral dose of BIIB061 3 mg.

Group Type: EXPERIMENTAL

BIIB061

Intervention Type: DRUG

BIIB061 capsules for oral administration

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.

Group Type: EXPERIMENTAL

BIIB061

Intervention Type: DRUG

BIIB061 capsules for oral administration

14C-BIIB061

Intervention Type: DRUG

Radiolabeled containing 14C-BIIB061 ≤ 500 nCi.

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).

Group Type: EXPERIMENTAL

BIIB061

Intervention Type: DRUG

BIIB061 capsules for oral administration

BIIB061 60 mg

Fasted participants will receive a single oral dose of BIIB061 60 mg.

Group Type: EXPERIMENTAL

BIIB061

Intervention Type: DRUG

BIIB061 capsules for oral administration

BIIB061 100 mg

Fasted participants will receive a single oral dose of BIIB061 100 mg.

Group Type: EXPERIMENTAL

BIIB061

Intervention Type: DRUG

BIIB061 capsules for oral administration

Interventions

BIIB061

BIIB061 capsules for oral administration

Intervention Type: DRUG

Placebo

BIIB061 matching placebo capsules

Intervention Type: DRUG

14C-BIIB061

Radiolabeled containing 14C-BIIB061 ≤ 500 nCi.

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

Research Site

Evansville, Indiana, United States

Research Site

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

231HV101

Identifier Type: -

Identifier Source: org_study_id