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Drug-drug interaction study with TS-142 in healthy adult subjects (concomitant administration of itraconazole)

Drug-drug interaction study with TS-142 in healthy adult subjects (concomitant administration of itraconazole)

10

Age (years): Mean+-SD 26.3+-6.8, Body Weight (kg): Mean+-SD 61.70+-6.47

10 subjects received the investigational product and completed the study.

No adverse events were observed.

The concomitant administration of TS-142 and itraconazole increased the Cmax and AUC, and prolonged the tmax and t1/2 of unchanged form compared to single administration of TS-142.

The plasma exposure was increased by the concomitant administration of TS-142 and itraconazole compared to a single administration of TS-142. No clinically relevant safety concerns were observed in TS-142 with concomitant itraconazole administration.

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2071200036

Mita Seiji

Taisho Pharmaceutical Co., LTD.

3-24,1, Takada, Toshima-Ku, Tokyo

shu_chiken@taisho.co.jp

Development ManagementDevelopment Headquarters

Taisho Pharmaceutical Co., LTD.

3-24,1, Takada, Toshima-Ku, Tokyo

+81-3-3985-1118

shu_chiken@taisho.co.jp

Complete

Oct. 05, 2020

Interventional

non-randomized controlled trial

open(masking not used)

uncontrolled control

single assignment

treatment purpose

To be eligible for study participation, an individual must meet all of the following criteria:

- Japanese male age 20 to 39 years at the signing of informed consent
- Subjects whose body mass index (BMI) within the range 18.5 - 25.0 kg/m2, exclusive of 25.0
- Subjects who judged by the principal investigator(s) or subinvestigator(s) to be appropriate as a subjects of this study based on the results of screening tests and the tests obtained prior to the administration of the investigational drug. (Those who have no abnormal findings in the physical examination, vital signs, and standard 12-lead ECG in the screening test and the test obtained prior to administration of the investigational drug, and whose clinical test results are within the standard values of the clinical trial site. However, if who showed abnormal findings but not clinically significant, they can be enrolled in clinical trials based on comprehensive consideration of medical viewpoints by the principal investigator(s) or subinvestigator(s).)
- Subjects who understand, and have willingness and ability to read and sign, the informed consent form

An individual who meets any of the following criteria will be excluded from participation in this study:

- Subjects who have any disease and are judged not to be healthy based on the medical viewpoints by the principal investigator(s) or subinvestigator(s)
- Subjects who have an inappropriate history for participation in this study, including hepatic, renal, cardiovascular, hematological, endocrinological, metabolic, respiratory, gastrointestinal, dermatological, neurological, urological, immunological, psychiatric abnormalities or diseases
- Subjects who have any history of drug or food allergies
- Other protocol defined exclusion criteria could apply

Male

Insomnia

Oral administration by capsule of TS-142, strength at 1 or 5 mg

Plasma concentration of compound(s)

+81-92-283-7701

Oct. 02, 2020

none