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

NCT02071121 | Completed Phase 1

• 1 other identifier: 231HV101
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

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

Keywords

BIIB061; Healthy

Outcome Measures

Primary Outcomes (1)

• Number of participants that experience adverse events (AEs) and Serious Adverse Events (SAEs)

  28 days

Secondary Outcomes (8)

• Area under the concentration-time curve from time 0 to infinity (AUCinf) of BIIB061

  Predose and up to 28 days post-dose.

• Maximum observed concentration (Cmax) of BIIB061

  Predose and up to 28 days post-dose.

• Time to reach maximum observed concentration (Tmax) of BIIB061

  Predose and up to 28 days post-dose.

• Half-life (t1/2) of BIIB061

  Predose and up to 28 days post-dose.

• Absolute bioavailability (Fabs) of BIIB061 for the absolute bioavailability cohort only

  Predose and up to 28 days post-dose.

Study Arms (6)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

BIIB061 3 mg

EXPERIMENTAL

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

Drug: BIIB061

BIIB061 10 mg

EXPERIMENTAL

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; Drug: 14C-BIIB061

BIIB061 30 mg

EXPERIMENTAL

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 60 mg

EXPERIMENTAL

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

Drug: BIIB061

BIIB061 100 mg

EXPERIMENTAL

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

Drug: BIIB061

Interventions

BIIB061 DRUG

BIIB061 capsules for oral administration

BIIB061 10 mg; BIIB061 100 mg; BIIB061 3 mg; BIIB061 30 mg; BIIB061 60 mg

Placebo DRUG

BIIB061 matching placebo capsules

Placebo

14C-BIIB061 DRUG

Radiolabeled containing 14C-BIIB061 ≤ 500 nCi.

BIIB061 10 mg

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (2)

Research Site

Evansville, Indiana, 47710, United States

Location

Research Site

Madison, Wisconsin, 53704, United States

Location

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2014
• First Posted: February 25, 2014
• Study Start: December 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: February 2, 2015

Record last verified: 2014-10

Locations

US (2)