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Clinical Pharmacology Study of CS-3150 Drug-drug interaction Study between CS-3150 and digoxin or rifampicin in healthy Japanese subjects.

Clinical Pharmacology Study of CS-3150 Drug-drug interaction Study between CS-3150 and digoxin or rifampicin 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 20 subjects who were confirmed to be eligible were enrolled in the study. One subjects withdrew from the study. As well as study 1, in study 2, a total of 12 subjects enrolled in the study. One subjects withdrew from the study.

- In study 1, treatment emerged adverse events (TEAEs) were reported in 3 of 2 subjects and occurrence was 10.0% (2/20), which was not considered by the investigator to be causally related to treatment. In study 2, TEAEs were reported in 2 of 2 subjects and occurrence was 16.7% (2/12), which were 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. They were considered by the investigator to be causally related to treatment. - TEAEs leading to study discontinuation occurred in 1 subject in each study. Among them, TEAEs which were considered related to study drug occurred in 1 subject in study 2. - 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, Ctrough, and AUCtau for digoxin plus esaxerenone versus digoxin alone were 1.130 (0.998-1.280), 1.088 (1.033-1.145), and 1.072 (1.015-1.133), respectively. In study 2, GLSM ratios (90% CI) for Cmax, AUClast, and AUCinf for esaxerenone plus rifampicin versus esaxerenone alone were 0.659 (0.599- 0.724), 0.315 (0.300-0.332), and 0.312 (0.297-0.328), respectively.

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

In study 1, digoxin Cmax at steady state was increased by 1.13 fold when digoxin 0.25 mg was coadministered with esaxerenone 5 mg. However, digoxin Ctrough and AUC were not increased. In study 2, esaxerenone Cmax and AUC were decreased by 0.31 fold and 0.66 fold, respectively, when esaxerenone 5 mg was coadministered with rifampicin 600 mg. It was considered that there were no safety concerns when esaxerenone was coadministered with either digoxin or amlodipine.

No

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DAIICHI SANKYO Co.,Ltd.

dsclinicaltrial@daiichisankyo.co.jp

DAIICHI SANKYO Co.,Ltd.

dsclinicaltrial@daiichisankyo.co.jp

completed

Jan. 26, 2017

Interventional

A single-center, open-label, 1 sequence cross-over 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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Dec. 17, 2016