This is a Phase 1, open-label, randomized, four-period, crossover study in healthy females of nonchildbearing potential and male subjects - to be conducted at a single center in the United States. The study will consist of a screening phase, a baseline phase, four treatment periods, and a follow-up phone call. The 4 treatment periods are divided into two pairs (Period 1 and 2 and Period 3 and 4), potentially separated by an intermission during which subjects will be discharged from the research unit: Periods 1 and 2 support relative bioavailability (RBA) estimation, while Periods 3 and 4 support estimation of PPI effects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
24
Rabeprazole
CC-92480
PPD Phase 1 Clinic
Austin, Texas, United States
Pharmacokinetics - AUC0-∞ (Reference Formulation)
Area under the plasma concentration-time curve from time zero to infinity
Time frame: Up to 5 days
Pharmacokinetics - AUC0-∞ (Test Formulation)
Area under the plasma concentration-time curve from time zero to the last observable concentration at time t
Time frame: Up to 5 days
Pharmacokinetics -Cmax (Reference Formulation)
Maximum plasma concentration
Time frame: Day 1
Pharmacokinetics - Cmax (Test Formulation)
Maximum plasma concentration
Time frame: Day 1
Pharmacokinetics - AUC0-t (Reference Formulation)
Area under the plasma concentration-time curve from time zero to the last observable concentration at time t
Time frame: Up to 5 days
Pharmacokinetics - AUC0-t (Test Formulation)
Area under the plasma concentration-time curve from time zero to the last observable concentration at time t
Time frame: Up to 5 days
Pharmacokinetics -Tmax (Reference Formulation)
Time to peak (maximum) plasma concentration
Time frame: Day 1
Pharmacokinetics -Tmax (Test Formulation)
Time to peak (maximum)plasma concentration
Time frame: Day 1
Pharmacokinetics - CL/F (Reference Formulation)
Apparent total plasma clearance
Time frame: Up to 5 days
Pharmacokinetics - CL/F (Test Formulation)
Apparent total plasma clearance
Time frame: Up to 5 days
Pharmacokinetics - Vz/F (Reference Formulation)
Apparent volume of distribution
Time frame: Up to 5 days
Pharmacokinetics - Vz/F (Test Formulation)
Apparent volume of distribution
Time frame: Up to 5 days
Pharmacokinetics - t1/2 (Reference Formulation)
Terminal elimination half-life
Time frame: Up to 5 days
Pharmacokinetics - t1/2 (Test Formulation)
Terminal elimination half-life
Time frame: Up to 5 days
Adverse Events (AEs)
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values (as specified by the criteria in Section 10.3), regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
Time frame: From enrollment until at least 28 days after completion of study treatment
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