This study will have three parts: Part A, Part B, and Part C. The primary purpose of Part A is to evaluate the effect of food on the rate and extent of E7090 absorption following single oral doses of E7090 in healthy participants, Part B is to evaluate the effects of rabeprazole (a gastric acid-reducing agent) on the rate and extent of E7090 absorption following single oral doses of E7090 in healthy participants, Part C is to evaluate the effects of rifampin (a strong Cytochrome P450 3A \[CYP3A\] inducer) on pharmacokinetics (PK) of single oral doses of E7090 in healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Oral tablet.
Rabeprazole 20 mg (2 tablets, each of 10 mg) oral tablet.
Rifampin 600 mg (4 capsules, each of 150 mg) oral capsule.
Eisai trial site #1
Minatoku, Tokoyo, Japan
Cmax: Maximum Observed Plasma Concentration of E7090
Time frame: 0-144 hours post-dose following E7090 administration
AUC(0-t): Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration of E7090
Time frame: 0-144 hours post-dose following E7090 administration
AUC(0-inf): Area Under the Concentration-time Curve From Zero (Pre-dose) Extrapolated to Infinite Time of E7090
Time frame: 0-144 hours post-dose following E7090 administration
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of E7090
Time frame: 0-144 hours post-dose following E7090 administration
AUC(0-72Hours): Area Under the Plasma Concentration Versus Time Curve from Time 0 to 72 Hours of E7090
Time frame: 0-144 hours post-dose following E7090 administration
T1/2: Terminal Half-life of E7090
Time frame: 0-144 hours post-dose following E7090 administration
CL/F: Apparent Total Body Clearance of E7090
Time frame: 0-144 hours post-dose following E7090 administration
Vz/F: Apparent Volume of Distribution at Terminal Phase of E7090
Time frame: 0-144 hours post-dose following E7090 administration
AUC Metabolite (M) Ratio: Ratio of AUC(0-inf) of M2 to AUC(0-inf) of E7090
Time frame: 0-144 hours post-dose following E7090 administration
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