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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04504760
• Other study ID #: ONO-2910-01
• Status: Completed
• Phase: Phase 1
• Start date: July 10, 2020
• Est. completion date: March 18, 2021

Study information

• Verified date: May 2024
• Source: Ono Pharmaceutical Co. Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 18, 2021
• Est. primary completion date: March 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• ONO-2910
Single ascending dose of ONO-2910 will be administered orally.
• Placebo
Single dose of placebo will be administered orally.
• ONO-2910
Multiple ascending dose of ONO-2910 will be administered orally.
• Placebo
Multiple dose of placebo will be administered orally.

Locations

Country	Name	City	State
Japan	Tokyo Clinical Site 01	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events [Safety and Tolerability]	Number of participants with adverse events as assessed by CTCAE v5.0	Up to 13 days
Secondary	Cmax [Pharmacokinetic]	Assessment of the Cmax of ONO-2910	Up to 10 days
Secondary	Tmax [Pharmacokinetic]	Assessment of the Tmax of ONO-2910	Up to 10 days
Secondary	AUC24h [Pharmacokinetic]	Assessment of the AUC24h of ONO-2910	Up to 10 days
Secondary	AUClast [Pharmacokinetic]	Assessment of the AUClast of ONO-2910	Up to 10 days
Secondary	AUCinf [Pharmacokinetic]	Assessment of the AUCinf of ONO-2910	Up to 10 days
Secondary	T1/2 [Pharmacokinetic]	Assessment of the T1/2 of ONO-2910	Up to 10 days
Secondary	CL/F [Pharmacokinetic]	Assessment of the CL/F of ONO-2910	Up to 10 days
Secondary	fe [Pharmacokinetic]	Assessment of the Vss of ONO-2910	Up to 4 days
Secondary	CLr [Pharmacokinetic]	Assessment of the CLr of ONO-2910	Up to 4 days