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A Drug-Drug Interaction Study of TAS5315 with CYP3A inhibitor in Healthy Adult Subjects

A Drug-Drug Interaction Study of TAS5315 with CYP3A inhibitor in Healthy Adult Subjects

Nasermoaddeli Ali

Taiho Pharmaceutical Co., Ltd.

1-27 Kandanishiki-cho, Chiyoda-ku, Tokyo

th-tas5315_clinical@taiho.co.jp

Suto Kotaro

Taiho Pharmaceutical Co., Ltd.

1-27 Kandanishiki-cho, Chiyoda-ku, Tokyo

+81-3-3293-2455

th-tas5315_clinical@taiho.co.jp

Complete

May. 01, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1) Aged 18 or older and younger than 40 years at the time of consent
2) Weigh at least 45.0 kg at the time of screening tests with a body mass index (BMI, weight [kg]/[height {m}]2) ranging from 18.0 to < 25.0 kg/m2
3) Blood pressure and body temperature obtained in screening tests within the following ranges
a Systolic blood pressure (in supine position), 90 to 139 mmHg
b Diastolic blood pressure (in supine position), 40 to 89 mmHg
c Body temperature ranging from 35.0 to 37.4
4) Judged to be healthy by the investigator based on the examination findings (subjective symptoms and objective findings), blood pressure, pulse rate, body temperature, 12-lead ECG, and laboratory tests (hematology test, biochemistry test, and urinalysis) at the time of screening tests

1) Had any concurrent disease (including symptoms and signs; however, diseases that do not affect evaluations in the study such as asymptomatic pollinosis and wart are excluded)

2) Had any severe disease history that may recur during the study period.

Both

healthy adult males and females

Orally administration of TAS5315 (1mg) and Itraconazole (200mg)

Maximum observed plasma concentration (Cmax) of TAS5315, area under the plasma concentration-time curve from the time of dosing to the time of last quantifiable plasma concentration (AUClast) of TAS5315, area under the plasma concentration-time curve from the time of dosing extrapolated to infinity (AUCinf) of TAS5315

+81-92-283-7701

April. 13, 2023

No

IPD data will not be shared according to the Sponsor policy on data sharing. Taiho clinical trial information disclosure policy may be found at https://www.taiho.co.jp/en/science/policy/clinical_trial_information_disclosure_policy/index.html

none