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

Phase 1

Terminated

• Conditions: Healthy Adult Subjects
• Interventions: Drug: ONO-4053; Drug: Placebo

• Registration Number: NCT01379586
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-21
• Study First Submitted QC: 2011-06-21
• Study First Posted: 2011-06-23
• Primary Completion: 2011-07
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-12
• Last Update Posted: 2012-06-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
E	ONO-4053	ONO-4053
P	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of ONO-4053 across ascending single and multiple doses using adverse events, vital signs, 12-lead ECG, continuous ECG monitoring and clinical lab tests.	At protocol-specified timepoints before and after study drug administration up to Day 14

Secondary Outcome Measures

Name	Time	Method
Plasma and urine concentrations of ONO-4053 and derived pharmacokinetic parameters	At protocol-specified timepoints before and after study drug administration up to Day 14

Trial Locations

Locations (1)

Leeds Clinical Site; 🇬🇧 Leeds, West Yorkshire, United Kingdom