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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

28

The mean (range) age of the subjects was 25.4 (20 to 44) years, the mean body weight was 61.06 kg, and the mean BMI was 21.45 kg/m2. No remarkable differences among the sequences were found in the demographic or other baseline characteristics. The demographic and other baseline characteristics of the pharmacokinetic analysis set were identical to those of the safety analysis.

Of 74 subjects enrolled, 28 were randomized to and completed the study.

The overall incidence of TEAEs was 10.7% (3/28 subjects): no TEAEs occurred under fasted conditions, and the incidence was 10.7% (3 subjects) under fed conditions. The TEAEs that occurred under fed conditions were nasopharyngitis, diarrhea, and ligament sprain. These TEAEs were reported in 1 subject each. All two episodes of ligament sprain (reported in the same subject were Grade 2, while nasopharyngitis and diarrhea were Grade 1. Nasopharyngitis and one episode of ligament sprain were resolved with medication. No TEAEs were considered to be related to the study drug. No deaths, serious TEAEs, TEAEs resulting in study withdrawal, or TEAEs of Grade 3 or higher were reported in the study.

- PK of total DS-3201a Following a single oral administration of DS-3201b, Cmax and AUC of total DS-3201a were decreased under fed condition compared with under fasted condition. The geometric least square mean ratios (90% CIs) of Cmax, AUClast, and AUCinf of total DS-3201a under fed conditions to those under fasted conditions were 0.375 (0.246 to 0.571), 0.462 (0.323 to 0.660), and 0.466 (0.327 to 0.663), respectively. The median Tmax of total DS-3201a after administration of DS-3201b was delayed under fed conditions compared with under fasted conditions (5.50 h vs. 3.00 h). - PK of unbound DS-3201a Following a single oral administration of DS-3201b, Cmax and AUC of unbound DS-3201a were decreased under fed condition compared with under fasted condition. The geometric least square mean ratios (90% CIs) of Cmax, AUClast, and AUCinf of unbound DS-3201a under fed conditions to those under fasted conditions were 0.325 (0.200 to 0.529), 0.425 (0.284 to 0.635), and 0.450 (0.306 to 0.662), respectively. The median Tmax of unbound DS-3201a after administration of DS-3201b was delayed under fed conditions compared with under fasted conditions (5.50 h vs. 3.00 h). - Safety Refer to "Adverse events" section.

Food (low-fat meal) decreased the total DS-3201a Cmax and AUC by approximately 60% and 50%, respectively, relative to those under fasted conditions. No new safety concerns were identified when DS-3201b was administered under fasted and fed conditions.

Aug. 11, 2023

https://accp1.onlinelibrary.wiley.com/doi/10.1002/cpdd.1315

No

https://jrct.niph.go.jp/latest-detail/jRCT2071200043

Nagao Kiminori

DAIICHI SANKYO Co.,Ltd.

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

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

Complete

Nov. 09, 2020

Interventional

randomized controlled trial

open(masking not used)

uncontrolled control

crossover assignment

other

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.

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

+81-92-283-7701

Oct. 23, 2020

none