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ONO-4578-07:relative bioavailability and food effect study in healthy adult subjects

ONO-4578-07 relative bioavailability and food effect study

15

Healthy adult males (a mean age of 29.4 years)

A single-center, open-label, randomized, 3-way, 3-period, crossover study was conducted in a total of 15 healthy Japanese adult males (5 subjects per group). Subjects received a single oral dose of the ONO-4578 reference formulation in the fasted state, a single oral dose of the ONO-4578 test formulation in the fasted state, and test formulation in the fed state. All 14 subjects enrolled in the study received the study drug as scheduled in each period, except for 1 subject. One subject discontinued the intervention period due to an AE in Period 2 and did not receive the study drug in Period 3.

After administration of the reference formulation in the fasted state, the test formulation in the fasted state, and test formulation in the fed state, AEs were observed in 3 of 15 subjects (20.0%), 1 of 15 subjects (6.7%), and 1 of 14 subjects (7.1%), respectively. Of these AEs, an AE in 1 subject (6.7%) after receiving the reference formulation in the fasted state (decreased appetite, Grade 1), an AE in 1 subject (6.7%) after receiving the test formulation in the fasted state (duodenal ulcer haemorrhage, Grade 3), and an AE in 1 subject (7.1%) after receiving the test formulation in the fed state (abdominal discomfort, Grade 2) were considered adverse drug reactions.

The geometric mean ratios of Cmax and AUClast of the test formulation to those of the reference formulation were 1.14 and 1.08, respectively. The geometric mean ratios of Cmax and AUClast were both within the range of 0.80 to 1.25. The relative bioavailability of the test formulation to the reference formulation, calculated from the geometric mean ratios of Cmax and AUClast, was 114% and 108%, respectively. The geometric mean ratios of Cmax and AUClast of the test formulation fed to those of the test formulation fasted were 0.99 and 0.88, respectively. The geometric mean ratios of Cmax and AUClast were both within the range of 0.80 to 1.25.

The relative bioavailability of the test formulation to the reference formulation was 114% and 108%, respectively. Dose adjustment between the reference formulation and the test formulation was considered unnecessary.The effect of food on the PK of the test formulation was considered small. The safety of a single oral dose of the ONO-4578 test formulation in the fasted state and in the fed state was within the range of the known risks, and it was considered that there was no problem in tolerability.

Oct. 05, 2022

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2071210056

Osawa Masahiro

Ono Pharmaceutical Co.,LTD

3 -1 -1 Sakurai, Shimamoto-cho, Mishima-gun, Osaka 618-8585, Japan

clinical_trial@ono.co.jp

Center Information Medical

Ono Pharmaceutical Co.,LTD

3 -1 -1 Sakurai, Shimamoto-cho, Mishima-gun, Osaka 618-8585, Japan

+81-120626190

clinical_trial@ono.co.jp

Complete

Sept. 09, 2021

Interventional

randomized controlled trial

open(masking not used)

active control

crossover assignment

other

Japanese healthy adult male, >=20 and <=40 of age, >=18.5 and <25.0 of BMI

Medical history of severe disease, severe allergy for foods and drugs

Male

Solid Cancer

Single administration of ONO-4578 for each period ( 3 periods scheduled)

relative bioavailability , food effect on ONO-4578

+81-92-283-7701

Aug. 30, 2021

none