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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: ONO-2910; Drug: ONO-2910; Drug: Placebo; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Tokyo Clinical Site 01

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo (Part A)	Drug: Placebo; Single dose of placebo will be administered orally.; Drug: Placebo; Multiple dose of placebo will be administered orally.
Experimental: ONO-2910 (Part A and B)	Drug: ONO-2910; Single ascending dose of ONO-2910 will be administered orally.; Drug: ONO-2910; Multiple ascending dose of ONO-2910 will be administered orally.
Experimental: ONO-2910 (Part C and D)	Drug: ONO-2910; Single ascending dose of ONO-2910 will be administered orally.; Drug: ONO-2910; Multiple ascending dose of ONO-2910 will be administered orally.
Placebo Comparator: Placebo (Part C and D)	Drug: Placebo; Single dose of placebo will be administered orally.; Drug: Placebo; Multiple dose of placebo will be administered orally.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ono Pharmaceutical Co. Ltd
• Investigators: Study Director: Masaharu Komeno, Ono Pharmaceutical Co. Ltd

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2020
• Primary Completion (Actual): March 18, 2021
• Study Completion (Actual): March 18, 2021

Study Registration Dates

• First Submitted: July 31, 2020
• First Submitted That Met QC Criteria: August 5, 2020
• First Posted (Actual): August 7, 2020

Study Record Updates

• Last Update Posted (Estimated): May 3, 2024
• Last Update Submitted That Met QC Criteria: May 2, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: ONO-2910-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: https://www.ono.co.jp/eng/rd/policy.html

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No