This is a Phase 1, fixed sequence, open-label study to evaluate the effect of multiple oral doses of rabeprazole on the pharmacokinetics of a single dose of vadadustat 300 mg in healthy male and female subjects.
This is a Phase 1, fixed sequence, open-label study in healthy adult subjects to evaluate the effect of multiple doses of rabeprazole on the pharmacokinetics of a single dose of vadadustat in healthy male and female subjects. Approximately twenty (20) subjects, with at least 30% female subjects, will be enrolled to ensure 18 evaluable subjects. Subjects will be on study for up to 66 days, including a 28-day screening period, 9-day clinic period, and a 30-day follow- up period post last dose. Subjects who are confirmed eligible and receive at least one dose of study drug will be considered enrolled in the study. Blood samples for PK analysis will be collected at pre-defined time points throughout the study up to 48 hours post administration of vadadustat.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Vadadustat 300 mg
Oral Rabeprazole
inVentiv Health Clinique Inc.
Québec, Quebec, Canada
Area under plasma concentration-time curve from 0 to last quantifiable concentration (AUClast) for vadadustat
Time frame: Up to 10 weeks
Area under plasma concentration-time curve from 0 to infinity (AUCinf) for vadadustat
Time frame: Up to 10 weeks
Maximum observed plasma concentration (Cmax) for vadadustat
Time frame: Up to 10 weeks
Time to maximum observed plasma concentration (Tmax) of vadadustat
Time frame: Up to 10 weeks
Elimination rate constant (Kel) of vadadustat
Time frame: Up to 10 weeks
Terminal half-life (t½) of vadadustat
Time frame: Up to 10 weeks
Apparent total body clearance (CL/F) of vadadustat
Time frame: Up to 10 weeks
Percent of extrapolated area under the curve from time t to infinity (%AUCextrap) of vadadustat
Time frame: Baseline and end of study
Area under plasma concentration-time curve from 0 to last quantifiable concentration (AUClast) of vadadustat-O-glucuronide
Time frame: Up to 10 weeks
Area under plasma concentration-time curve from 0 to infinity (AUCinf) of vadadustat-O-glucuronide
Time frame: Up to 10 weeks
Maximum observed plasma concentration (Cmax) of vadadustat-O-glucuronide
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Time frame: Up to 10 weeks
Reporting of treatment emergent adverse event (TEAE) as reported by study subjects
Time frame: Up to 10 weeks