Japanease

Oct. 13, 2020

Feb. 05, 2021

jRCT2071200043

Phase 1 study of DS-3201b to evaluate the effect of food (low-fat meal) on the pharmacokinetics in healthy subjects

Phase 1 study of DS-3201b to evaluate the effect of food (low-fat meal) on the pharmacokinetics in healthy subjects

Nagao Kiminori

DAIICHI SANKYO Co.,Ltd.

1-2-58, Hiromachi, Shinagawa-ku, Tokyo

+81-3-6225-1111

dsclinicaltrial@daiichisankyo.co.jp

Contact for Clinical Trial Information

DAIICHI SANKYO Co.,Ltd.

1-2-58, Hiromachi, Shinagawa-ku, Tokyo

+81-3-6225-1111

dsclinicaltrial@daiichisankyo.co.jp

Oct. 31, 2020

28

Interventional

randomized controlled trial

open(masking not used)

uncontrolled control

crossover assignment

other

none

1. Gender:males or females
2. Age: >=20 and =<45 years (at the time of informed consent)
3. Body mass index (BMI) = Body weight (kg) / (Height [m])2: >=18.5 and <25.0 (at screening)

1. Having a history of hypersensitivity to any drugs or substances, or being idiosyncratic (eg, having penicillin allergy)
2. Having alcohol or drug dependence etc.

20age old over
45age old under

Both

Healthy subjects

Oral administration

Pharmacokinetic parameters of plasma concentration of total DS-3201a:
Cmax, AUClast, AUCinf

PK:
Plasma PK parameters for DS-3201a (total and unbound concentrations)
Safety:
AEs, laboratory data, body weight, vital signs, and 12-lead ECGs

Complete

DAIICHI SANKYO Co.,Ltd.
Hakata Clinic Institutional Review Board
6-18, Tenyamachi, Hakata-ku, Fukuoka-shi, Fukuoka

+81-92-283-7701

Approval

Oct. 23, 2020

No