A Phase I Study to Evaluate Safety, Tolerability and Pharmacokinetics of ONO-4053 in Healthy Volunteers

Ono Pharmaceuticals

Status and phase

Terminated

Phase 1

Conditions

Healthy Adult Subjects

Treatments

Drug: ONO-4053

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01379586

Eudra CT No. 2010-023049-31

ONO-4053POE001

Details and patient eligibility

About

The primary objective of this study is to evaluate the safety and tolerability of ONO-4053 across ascending single and multiple doses in healthy adult male and female subjects. The secondary objective of the study is to characterize the pharmacokinetic profile of ONO-4053 in healthy adult male and female subjects.

Full description

This is a first-in-human study of ONO-4053 in healthy volunteers. This study consists of three parts. Part A will investigate the safety, tolerability and pharmacokinetics when single ascending doses of ONO-4053 are administered in a double-blind manner. Part B will investigate the pharmacokinetics of ONO-4053 in the fed and fasted state in an open-label manner. Part C will investigate the safety, tolerability and pharmacokinetics when multiple ascending doses of ONO-4053 are administered in a double-blind manner. Doses for Part B and C will be determined after data from Part A are available.

Enrollment

15 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy caucasian subjects aged 18-45 years inclusive
Subjects with a body mass index of 19-30 kg/m2 inclusive and who weigh at least 50 kg and no more than 100 kg at screening.

Exclusion criteria

Subjects who have a clinically relevant history or presence of any clinically significant disease or disorder.
Current smokers or those that have smoked or used nicotine products within 6 months of the Screening visit.