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Clinical Pharmacology Study of CS-3150 Drug-drug interaction study between CS-3150 and amlodipine in healthy Japanese subjects

Clinical Pharmacology Study of CS-3150 Drug-drug interaction study between CS-3150 and amlodipine in healthy Japanese subjects

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The subject demographics and characteristics for the safety analysis set was similar to those for the pharmacokinetic analysis set.

In study 1, after obtaining informed consent for the study, a total of 24 subjects who were confirmed to be eligible were enrolled in the study. There were 2 subjects withdrawn from the study. As well as study 1, in study 2, a total of 20 subjects enrolled in the study. There were 2 subjects withdrawn from the study.

- In study 1, treatment emerged adverse events (TEAEs) were reported in 4 of 2 subjects and occurrence was 8.3% (2/24), which was not considered by the investigator to be causally related to treatment. In study 2, TEAEs were reported in 1 of 1 subjects and occurrence was 5.0% (1/20), which were not considered by the investigator to be causally related to treatment. - In both study, no deaths and other serious adverse events were reported in the study. - TEAEs leading to study discontinuation occurred in 1 subject in each study. All TEAEs were considered unrelated to study drug. - Except for the abnormal change in the laboratory values reported TEAEs, no clinically relevant changes from baseline were seen in laboratory parameters, vital signs, or 12-lead ECG parameters.

In study 1, geometric least-square mean (GLSM) ratios (90% CI) for Cmax, AUClast, and AUCinf for esaxerenone plus amlodipine versus esaxerenone alone were 0.958 (0.905-1.015), 1.154 (1.118-1.190), and 1.173 (1.136-1.212), respectively. In study 2, GLSM ratios (90% CI) for Cmax, AUClast, and AUCinf for amlodipine plus esaxerenone versus amlodipine alone were 1.099 (1.059-1.140), 1.185 (1.132-1.240), and 1.214 (1.157-1.273), respectively.

Please refer to "adverse events" section since secondary outcome measures in the study are safety.

In study 1, the pharmacokinetics of esaxerenone was not affected by amlodipine when esaxerenone 2.5 mg was coadministered with amlodipine 10 mg. In study 2, AUC for amlodipine was increased by approximately 1.2 fold, but Cmax for amlodipine was not increased when amlodipine 2.5 mg was coadministered with esaxerenone 5 mg. It was considered that there were no safety concerns when esaxerenone was administered concomitantly with amlodipine.

No

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DAIICHI SANKYO Co.,Ltd.

dsclinicaltrial@daiichisankyo.co.jp

DAIICHI SANKYO Co.,Ltd.

dsclinicaltrial@daiichisankyo.co.jp

completed

Nov. 14, 2016

Interventional

A single-center, open-label, 1 sequence crossover study

other

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1) Japanese male
2) Persons >= 20 years and =< 45 years of age at the time of informed consent
3) Persons with a body mass index (BMI; calculated by body weight [kg]/height [m]2) of >= 18.5 kg/m2 and < 25.0 kg/m2 at the screening examination

1) Persons with hypersensitivity or idiosyncratic reactions to a drug, (such as penicillin allergy)
2) Persons with drug or alcohol dependence

Male

Healthy volunteers

investigational material(s)
Generic name etc : CS-3150
INN of investigational material : esaxerenone
Therapeutic category code : 214 Antihypertensives
Dosage and Administration for Investigational material : Oral

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

pharmacokinetics
Pharmacokinetics and safety

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Sept. 21, 2016