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ONO-1110-03 : An Open-label Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ONO-1110 after Single Oral Administration in Japanese Healthy Adult Male Subjects

ONO-1110-03 : A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ONO-1110 in Healthy Japanese Adult Male Subjects

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This study was conducted on healthy adult Japanese males aged between 18 and 45 years.

This study was an open-label, single arm, two-period crossover study. This study consisted of a screening period, Period 1, and Period 2. ONO-1110 tablets were administered orally in a single dose under fasted condition in Period 1, and under fed condition in Period 2. This study was conducted under admission to the study site for 8 nights and 9 days, from the day before dosing in Period 1 (fasted condition) to the completion of Period 2 (fed condition).

No adverse events were observed in this study. There were no fatal adverse events, serious adverse events, or adverse events leading to treatment discontinuation. No clinically significant changes were observed in laboratory tests, vital signs, 12-lead electrocardiograms, and other relevant examinations.

Plasma ONO-1110 concentrations increased rapidly after administration of the study drug in the fasted condition (Period 1) than in the fed condition (Period 2), reaching the maximum plasma concentration (Cmax) at 0.75 hours and 2 hours, respectively. Thereafter, plasma concentrations declined rapidly in both conditions, falling below the limit of quantification at 72 hours post-dose. Summary statistics for plasma ONO-1110 pharmacokinetic parameters (mean +/- standard deviation, and median [minimum - maximum] for Tmax) were as follows: in the fasted (Period 1) and fed (Period 2) conditions, Cmax was 2880 +/- 592 and 2940 +/- 561 ng/mL, Tmax was 0.750 (0.500 - 2.00) and 2.00 (1.00 - 3.00) hours, AUClast was 8650 +/- 2790 and 9270 +/- 2190 ng*h/mL, AUCinf was 8660 +/- 2790 and 9270 +/- 2190 ng*h/mL, T1/2 was 2.93 +/- 1.56 and 2.66 +/- 0.646 hours, and CL/F was 22.8 +/- 8.10 and 20.3 +/- 4.63 L/h, respectively. The geometric mean ratios (90% confidence intervals) of Cmax, AUCinf, and AUClast for the fed condition (Period 2) relative to the fasted condition (Period 1) were 1.02 (0.78 - 1.33), 1.10 (0.99 - 1.21), and 1.10 (0.99 - 1.21).

The pharmacokinetics of a single oral dose of ONO-1110 tablet 180 mg were similar to those of the ONO-1110 suspension. Furthermore, no adverse events, clinically significant changes in laboratory values or other relevant examinations were observed during this study. Therefore, the formulation change from suspension to tablet is unlikely to affect the safety and tolerability of ONO-1110.

Oct. 01, 2025

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2071240014

Namba Yoshinobu

Ono Pharmaceutical Co.,LTD

3 -1 -1 Sakurai, Shimamoto-cho, Mishima-gun, Osaka

clinical_trial@ono-pharma.com

Medical Information Center

Ono Pharmaceutical Co.,LTD

3 -1 -1 Sakurai, Shimamoto-cho, Mishima-gun, Osaka

+81-120-626-190

clinical_trial@ono-pharma.com

Complete

June. 20, 2024

Interventional

single arm study

open(masking not used)

uncontrolled control

crossover assignment

treatment purpose

1) Healthy Japanese adult males
2) The subject is aged 18 to 45 years, inclusive, at the time of signing the informed consent form.
3) The subject has a BMI of 18.5 kg/m2 or more and less than 25.0 kg/m2 (rounded down to 2 decimal places) at screening.

1) An individual who is receiving treatment for or has a history of a respiratory, cardiovascular, psychiatric, neurological, gastrointestinal, immunological, hepatic, renal, hematopoietic, endocrine, or other disease
2) Subjects with current or perious history of severe allergy to drugs or food
3) The subject who is judged by the investigator or subinvestigator to be inappropriate as a subject of this study based on the results of screening tests

Male

Healthy volunteers

Subjects receive a single oral dose of 180-mg ONO-1110.

Plasma ONO-1110 concentrations and pharmacokinetic parameters

Adverse events that occurred after administration of investigational product until the end of final examination

+81-92-283-7701

May. 30, 2024

none