The purpose of this study is to evaluate the effects of diltiazem on the pharmacokinetics (PK) and pharmacodynamics (PD) of E5555 and its metabolites in healthy subjects.
This is an open-label, 2-arm study to evaluate the effects of diltiazem given in conjunction with E5555 on the PK of diltiazem and its metabolites. This is a Phase 1 study of 24 healthy male and female subjects that will be conducted at a single site. The planned duration of treatment for each subject is approximately 15 days including 1 day in Treatment Period 1 and 14 days in Treatment Period 2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
E5555 single 100 mg oral dose in Treatment Period 1 Day 1 and in Treatment Period 2 Day 8. Diltiazem 360 mg orally each day for 14 days (Days 1-14) in Treatment Period 2.
E5555 single 300 mg oral dose in Treatment Period 1 and in Treatment Period 2 Day 8. Diltiazem 360 mg orally each day for 14 days (Days 1-14) in Treatment Period 2.
PRA International
Zuidlaren, Netherlands, Netherlands
Evaluate the effects of diltiazem on the pharmacokinetics (PK ie. Cmax, Tmax, AUC and half-life) of E5555 and its known metabolites.
Time frame: 18 days
Evaluate the effects of diltiazem on the thrombin- and thrombin receptor activating peptide (TRAP) -induced platelet aggregation of E5555 and its known metabolites
Time frame: 18 days
To evaluate the effects of co-adminstration of diltiazem and E5555 on the PK(ie. Cmax, Tmax, AUC and half-life) of diltiazem and its metabolites
Time frame: 18 days
To evaluate effects of co-adminstration of diltiazem and E5555 on QTcF compared to E5555 alone
Time frame: 18 days
To assess safety and tolerability of a single dose of E5555 when given alone or in combination with diltiazem by recording the number of all adverse events following drug administration
Time frame: 18 days
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