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A randomized, placebo-controlled, double-blind study to assess the safety, tolerability and pharmacokinetics of single and multiple doses of DS-5565 in healthy Chinese subjects

Single and multiple doses study of DS-5565 in healthy Chinese subjects

54

[Single Dose Part] The mean (SD) age was 27.6 (5.2), the mean (SD) body weight was 63.0 (9.8) kg, and mean BMI (SD) was 22.7 (2.2) kg/m2. No notable difference was found among the administration groups. [Multiple Dose Part] The mean (SD) age was 27.8 (4.7), the mean (SD) body weight was 60.7 (7.5) kg, and mean BMI (SD) was 22.5 (1.9) kg/m2. No notable difference was found among the administration groups.

After obtaining informed consent for the study, a total of 54 subjects (36 subjects for the single dose part and 18 subjects for the multiple dose part) who were confirmed to be eligible were enrolled in the study. There were no subjects withdrawn from the study.

- No deaths and other serious adverse events were reported in the study. - The incidence of treatment-emergent adverse events (TEAEs) in the single dose part was 66.7% (20/30) in the DS-5565 groups and 33.3% (2/6) in the placebo group. The incidence of adverse drug reactions (ADRs) was 20.0% (6/30) in the DS-5565 groups and 16.7% (1/6) in the placebo group. - The incidence of TEAEs in the multiple dose part was 85.7% (12/14) in the DS-5565 groups and 100.0% (4/4) in the placebo group. The incidence of ADRs was 57.1% (8/14) in the DS-5565 groups and 0.0% (0/4) in the placebo group. - The most common ADRs included central nervous system-related TEAEs such as dizziness and somnolence, which were expected based on the mechanism of action of DS-5565. - 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.

[Safety] - Please refer to "adverse events" section. [Pharmacokinetics] - Following a single oral dose of DS-5565, DS-5565 was rapidly absorbed with the median Tmax of 1.00 h, and was eliminated with the mean T1/2 ranging from approximately 2.57 h to 3.08 h. - In the single dose part, Cmax and AUC increased generally in a dose-proportional manner. The mean apparent clearance and volume of distribution (CL/F and Vz/F) remained nearly constant regardless of the DS-5565 dose level. - Following multiple oral doses of DS-5565, the median Tmax was 1.00 h, and the mean T1/2 was 3.86 h. - Cmax and AUCtau following multiple doses of DS-5565 were comparable to those following a single dose of DS-5565.

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DS-5565 was safe and well-tolerated at single doses of 5 mg to 15 mg and at multiple doses of up to 15 mg in healthy Chinese subjects.

Yes

Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/ Supporting Documents: - Study Protocol - Statistical Analysis Plan - Clinical Study Report Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication. Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent. URL: https://vivli.org/ourmember/daiichi-sankyo/

DAIICHI SANKYO Co.,Ltd.

dsclinicaltrial@daiichisankyo.co.jp

DAIICHI SANKYO Co.,Ltd.

dsclinicaltrial@daiichisankyo.co.jp

completed

Sept. 04, 2017

Interventional

A single-center, randomized, double-blind, placebo-controlled, single and multiple doses study.

other

1

1) Healthy Chinese
2) Aged 18 years to 45 years (inclusive), at the time of informed consent
3) Body weight of female >= 45 kg, male >= 50 kg, and a BMI in the range of 19.0 kg/m2 to 26.0 kg/m2 (inclusive) at screening

1) Hypersensitivity or idiosyncratic reactions to a drug (such as penicillin allergy)
2) Presence or history of any drug abuse or of alcohol abuse etc.

Both

Healthy volunteers

investigational material(s)
Generic name etc : DS-5565
INN of investigational material : Mirogabalin
Therapeutic category code : 119 Other agents affecting central nervous system
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 : -

safety
pharmacokinetics
Safety and pharmacokinetics

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Jan. 24, 2017