Clinical trial NCT02071121: Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB061 in Healthy Adult Volunteers Including Absolute Bioavailability and Food Effect
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: BIIB061
Healthy
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2014-02-25
Enrollment: 39
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of participants that experience adverse events (AEs) and Serious Adverse Events (SAEs)
timeFrame: 28 days
Secondary outcomes:
measure: Area under the concentration-time curve from time 0 to infinity (AUCinf) of BIIB061
timeFrame: Predose and up to 28 days post-dose.
measure: Maximum observed concentration (Cmax) of BIIB061
timeFrame: Predose and up to 28 days post-dose.
measure: Time to reach maximum observed concentration (Tmax) of BIIB061
timeFrame: Predose and up to 28 days post-dose.
measure: Half-life (t1/2) of BIIB061
timeFrame: Predose and up to 28 days post-dose.
measure: Absolute bioavailability (Fabs) of BIIB061 for the absolute bioavailability cohort only
timeFrame: Predose and up to 28 days post-dose.
measure: Clearance of BIIB061 for the absolute bioavailability cohort only.
timeFrame: Predose and up to 28 days post-dose.
measure: Volume of distribution (Vd) of BIIB061 for the absolute bioavailability cohort only.
timeFrame: Predose and up to 28 days post-dose.
measure: 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
timeFrame: 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)
Other outcomes:
Locations:
city: Evansville
country: United States
facility: Research Site
state: Indiana
city: Madison
country: United States
facility: Research Site
state: Wisconsin
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: