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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
Research Site
Evansville, Indiana, United States
Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 9 Days Post dose
Number of participants with clinically significant laboratory assessment abnormalities
Time frame: Up to 9 Days Post dose
Number of participants with clinically significant Vital sign abnormalities
Time frame: Up to 9 Days Post dose
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
Time frame: Up to 9 Days Post dose
Number of participants with clinically significant physical examination abnormalities
Time frame: Up to 9 Days Post dose
PK Assessment - Area Under the concentration-time curve from time zero to time of the Last Measurable Concentration (AUC0-tlast)
Time frame: Up to 48 Hours Post dose
PK Assessment - Area under the concentration-time curve from time 0 to infinity (AUCinf)
Time frame: Up to 48 Hours Post dose
PK Assessment - Maximum observed concentration (Cmax)
Time frame: Up to 48 Hours Post dose
PK Assessment - Time to reach maximum observed concentration (Tmax)
Time frame: Up to 48 Hours Post dose
PK Assessment - Terminal elimination half-life (t1/2)
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Time frame: Up to 48 Hours Post dose
PK Assessment - Apparent total body clearance (CL/F)
Time frame: Up to 48 Hours Post dose
PK Assessment - Apparent volume of distribution (Vz/F)
Time frame: Up to 48 Hours Post dose
PK Assessment - Amount of BIIB068 excreted in urine (Aeu)
Time frame: Up to 48 Hours Post dose
PK Assessment - Percentage (%fe) of BIIB068 excreted in urine
Time frame: Up to 48 Hours Post dose
PK Assessment - Renal clearance (CLr)
Time frame: Up to 48 Hours Post dose