臨床研究等提出・公開システム

An open-label, single-sequence crossover study to evaluate the effects of CS-3150 on the pharmacokinetics of midazolam in Japanese healthy subjects

CS-3150 midazolam DDI study

28

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

After obtaining informed consent for the study, a total of 28 subjects who were confirmed to be eligible were enrolled in the study. Two subjects withdrew from the study.

- Treatment emerged adverse events (TEAEs) were reported in 6 of 3 subjects and occurrence was 11% (3/28) in the study. Three TEAEs of a single subject were considered related to the study drug. - No deaths and other serious adverse events were reported in the study. - TEAE leading to study discontinuation occurred in 1 subject. The event was assessed as being related to treatment because a potential association could not be denied. - Except for the abnormal change in the laboratory values reported as TEAEs, no clinically relevant changes from baseline were seen in laboratory parameters, vital signs, or 12-lead ECG parameters.

Geometric least-square mean ratios (90% CI) for Cmax, AUClast, and AUCinf for midazolam plus esaxerenone versus midazolam alone were 1.224 (1.116-1.342), 1.201(1.110-1.300), 1.201 (1.112-1.297), respectively.

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

Esaxerenone increased midazolam Cmax and AUC by approximately 1.2 fold compared to administration of midazolam alone. It was considered that there were no safety concerns when midazolam was administered concomitantly with esaxerenone.

No

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DAIICHI SANKYO Co.,Ltd.

dsclinicaltrial@daiichisankyo.co.jp

DAIICHISANKYO Co.,Ltd.

dsclinicaltrial@daiichisankyo.co.jp

completed

Mar. 18, 2015

Interventional

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

other

1

1. Male Japanese
2. Between the age of 20 and 45
3. Between the BMI of 18.5 and 24.9
4. Sitting blood pressure : systolic blood pressure < 140 mmHg, and diastolic blood pressure < 90 mmHg
5. Pulse rate <=99 bpm

1. Presence or history of hypersensitivity or idiosyncratic reaction (penicillin allergy etc.) to a drug including midazolam.
2. Presence or history of drug or alcohol dependence. etc.

Male

Healthy volunteers

investigational material(s)
Generic name etc : CS-3150
INN of investigational material : -
Therapeutic category code : 214 Antihypertensives
Dosage and Administration for Investigational material : 1 dose level (Oral)

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

pharmacokinetics
The PK parameters of midazolam

safety
pharmacokinetics
1. Other PK parameters of free form and metabolites of midazolam
2. The PK parameters of CS-3150
3. Safety

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Mar. 06, 2015