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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
39
BIIB061 capsules for oral administration
BIIB061 matching placebo capsules
Radiolabeled containing 14C-BIIB061 ≤ 500 nCi.
Research Site
Evansville, Indiana, United States
Research Site
Madison, Wisconsin, United States
Number of participants that experience adverse events (AEs) and Serious Adverse Events (SAEs)
Time frame: 28 days
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
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.
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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)