This study is primarily designed to bridge the pharmacokinetics (PK) and safety data for E2609 between Japanese subjects and non-Japanese (ie, white) subjects. To bridge these PK characteristics, the proposed study includes a cohort of white subjects treated for comparison with the cohort of Japanese subjects treated at the same dose. This comparison serves as a key PK bridge in assessing ethnic factors that may contribute to differences in plasma concentrations. Pharmacokinetic assessments in the proposed study will include confirmation of dose proportionality in Japanese subjects. This study will also evaluate safety and tolerability in Japanese subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
32
E2609 low-dose and placebo in healthy Japanese subjects, E2609 mid-dose and placebo in healthy Japanese subjects, E2609 high-dose and placebo in healthy Japanese subjects, E2609 mid-dose and placebo in healthy White subjects
Unnamed facility
Glendale, California, United States
Pharmacokinetics of E2609: Cmax
Time frame: Up to Day 10 (216 hours postdose)
Pharmacokinetics of E2609: tmax
Time frame: Up to Day 10 (216 hours postdose)
Pharmacokinetics of E2609: AUC(0-24h)+D90
Time frame: Up to Day 10 (216 hours postdose)
Pharmacokinetics of E2609: AUC(0-72h)
Time frame: Up to Day 10 (216 hours postdose)
Pharmacokinetics of E2609: AUC(0-t)
Time frame: Up to Day 10 (216 hours postdose)
Pharmacokinetics of E2609: AUC(0-inf)
Time frame: Up to Day 10 (216 hours postdose)
Pharmacokinetics of E2609: AUC Metabolite Ratio
Time frame: Up to Day 10 (216 hours postdose)
Pharmacokinetics of E2609: t1/2
Time frame: Up to Day 10 (216 hours postdose)
Pharmacokinetics of E2609: CL/F
Time frame: Up to Day 10 (216 hours postdose)
Pharmacokinetics of E2609: V/F
Time frame: Up to Day 10 (216 hours postdose)
To evaluate the safety and tolerability of E2609
Safety will be assessed by monitoring and recording all adverse events (AEs), serious adverse events (SAEs), regular monitoring of hematology, blood chemistry, urine values, regular measurement of vital signs, ECGs and performance of physical examinations
Time frame: Baseline and up to 30 days from last dosing of subject
Pharmacodynamic effect of E2609: percent change from baseline of plasma (AB[1-x]): Amax
Time frame: Baseline, Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, and Day 10
Pharmacodynamic effect of E2609: percent change from baseline of plasma (AB[1-x]): T(Amax)
Time frame: Baseline, Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, and Day 10
Pharmacodynamic effect of E2609: percent change from baseline of plasma (AB[1-x]): AUAC(-24h-0h)
Time frame: Baseline, Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, and Day 10
Pharmacodynamic effect of E2609: percent change from baseline of plasma (AB[1-x]): AUAC(0-144h)
Time frame: Baseline, Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, and Day 10
Pharmacodynamic effect of E2609: percent change from baseline of plasma (AB[1-x]): Change in AUAC
Time frame: Baseline, Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, and Day 10
Change from baseline in QTcF obtained from ECGs extracted from Holter recordings
Holter ECG measurements will start on Day -1, at a time equivalent to 24 hours predose, and will continue for 24 hours postdose of Day 1, with interruptions allowed to adjust equipment. ECGs will be extracted from Holter monitors.
Time frame: Baseline, Day 1, and Day 2
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.