A Phase 1, Single-Ascending-Dose, Safety, Tolerability, Pharmacokinetic(PK), and Pharmacodynamic(PD) Study of BIIB068 in Healthy Participants
- Registration Number
- NCT02829541
- Lead Sponsor
- Biogen
- Brief Summary
The primary objective of the study is to evaluate the safety and tolerability of single oral doses of BIIB068 in healthy participants. Secondary objectives are to characterize the single-oral-dose Pharmacokinetic (PK) of BIIB068 in healthy participants, to determine the effect of food on the single-oral-dose PK of BIIB068 in healthy participants and to examine the effect of administration of the proton pump inhibitor (PPI) esomeprazole on the single-dose PK of BIIB068 in healthy participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
- All male subjects must practice highly effective methods of contraception during the study and be willing and able to continue contraception and not donate sperm for at least 1 spermatogenic cycle (90 days) after administration of last dose of study treatment.
- All female subjects of childbearing potential must practice highly effective methods of contraception during the study and be willing and able to continue contraception for at least 1ovulatory cycle (30 days) after their last dose of study treatment.
- Must have a body mass index (BMI) between 18 and 32 kg/m2
- Must be in good health as determined by the Investigator, based on medical history and screening evaluations.
Key
Exclusion Criteria
- History of any clinically significant cardiac, endocrine, gastrointestinal (GI), hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
- History of severe allergic or anaphylactic reactions, or history of any allergic reactions that in the opinion of the Investigator is likely to be exacerbated by any component of the study treatment.
- Clinically significant abnormal laboratory test values, as determined by the Investigator, at Screening or Day-1.
NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 4 Placebo 8 participants randomized (6:2) to receive a SAD administered orally in tablet Cohorts 1 BIIB068 6 participants randomized (4:2) to receive a single-ascending dose (SAD) administered orally in tablet Cohorts 1 Placebo 6 participants randomized (4:2) to receive a single-ascending dose (SAD) administered orally in tablet Cohort 2 BIIB068 6 participants randomized (4:2) to receive a SAD administered orally in tablet(s) Cohort 2 Placebo 6 participants randomized (4:2) to receive a SAD administered orally in tablet(s) Cohort 3 BIIB068 8 participants randomized (6:2) to receive a SAD administered orally in tablet(s) Cohort 3 Placebo 8 participants randomized (6:2) to receive a SAD administered orally in tablet(s) Cohort 4 BIIB068 8 participants randomized (6:2) to receive a SAD administered orally in tablet Cohort 5 BIIB068 8 participants randomized (6:2) to receive a SAD administered orally in tablet(s) Cohort 5 Placebo 8 participants randomized (6:2) to receive a SAD administered orally in tablet(s) Cohort 6 BIIB068 14 participants (all active) to receive a SAD administered orally in tablet(s)
- Primary Outcome Measures
Name Time Method Number of participants with clinically significant Vital sign abnormalities Up to 9 Days Post dose Number of participants with clinically significant laboratory assessment abnormalities Up to 9 Days Post dose Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs) Up to 9 Days Post dose Number of participants with clinically significant physical examination abnormalities Up to 9 Days Post dose Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities Up to 9 Days Post dose
- Secondary Outcome Measures
Name Time Method PK Assessment - Time to reach maximum observed concentration (Tmax) Up to 48 Hours Post dose PK Assessment - Terminal elimination half-life (t1/2) Up to 48 Hours Post dose PK Assessment - Apparent volume of distribution (Vz/F) Up to 48 Hours Post dose PK Assessment - Amount of BIIB068 excreted in urine (Aeu) Up to 48 Hours Post dose PK Assessment - Area under the concentration-time curve from time 0 to infinity (AUCinf) Up to 48 Hours Post dose PK Assessment - Apparent total body clearance (CL/F) Up to 48 Hours Post dose PK Assessment - Percentage (%fe) of BIIB068 excreted in urine Up to 48 Hours Post dose PK Assessment - Renal clearance (CLr) Up to 48 Hours Post dose PK Assessment - Maximum observed concentration (Cmax) Up to 48 Hours Post dose PK Assessment - Area Under the concentration-time curve from time zero to time of the Last Measurable Concentration (AUC0-tlast) Up to 48 Hours Post dose
Trial Locations
- Locations (1)
Research Site
🇺🇸Evansville, Indiana, United States