Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and PK of ONO-2910 in Japanese and Caucasian Subjects

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Placebo; Drug: ONO-2910

• Registration Number: NCT04504760
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

Brief Summary

To investigate safety, tolerability and pharmacokinetics in Japanese and Caucasian subjects when ONO-2910 is administered as single and multiple doses orally.

Detailed Description

This study is the First in Human (FIH) study to investigate safety, tolerability and pharmacokinetics in healthy Japanese and Caucasian adult male subjects when ONO-2910 is administered as single and multiple doses orally. Also, the purpose of this study is to evaluate pharmacokinetics of oral single-dose of ONO-2910 in Japanese elderly male and female subjects.

Study Timeline

• Study Start: 2020-07-10
• Study First Submitted: 2020-07-31
• Study First Submitted QC: 2020-08-05
• Study First Posted: 2020-08-07
• Primary Completion: 2021-03-18
• Study Completion: 2021-03-18
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-02
• Last Update Posted: 2024-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Japanese healthy adult male subjects (Part A and C)
2. Japanese men or women after menopause aged ≥65 years and ≤74 years (Part B)
3. Caucasian healthy adult male subjects (Part D)
4. Age (at the time of informed consent): ≥20 years, ≤ 45 years (Part A, C and D)

Exclusion Criteria

1. Subjects currently with or with a history of disease
2. Subjects with current or with a history of severe allergy to drugs or foods
3. Subjects with current or with a history of drug or alcohol abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo (Part C and D)	Placebo	-
ONO-2910 (Part C and D)	ONO-2910	-
ONO-2910 (Part A and B)	ONO-2910	-
Placebo (Part A)	Placebo	-

Primary Outcome Measures

Name	Time	Method
Adverse events [Safety and Tolerability]	Up to 13 days	Number of participants with adverse events as assessed by CTCAE v5.0

Secondary Outcome Measures

Name	Time	Method
Cmax [Pharmacokinetic]	Up to 10 days	Assessment of the Cmax of ONO-2910
CLr [Pharmacokinetic]	Up to 4 days	Assessment of the CLr of ONO-2910
Tmax [Pharmacokinetic]	Up to 10 days	Assessment of the Tmax of ONO-2910
AUClast [Pharmacokinetic]	Up to 10 days	Assessment of the AUClast of ONO-2910
T1/2 [Pharmacokinetic]	Up to 10 days	Assessment of the T1/2 of ONO-2910
AUCinf [Pharmacokinetic]	Up to 10 days	Assessment of the AUCinf of ONO-2910
AUC24h [Pharmacokinetic]	Up to 10 days	Assessment of the AUC24h of ONO-2910
CL/F [Pharmacokinetic]	Up to 10 days	Assessment of the CL/F of ONO-2910
fe [Pharmacokinetic]	Up to 4 days	Assessment of the Vss of ONO-2910

Trial Locations

Locations (1)

Tokyo Clinical Site 01; 🇯🇵 Tokyo, Japan