Clinical Trials/NCT00956371

NCT00956371

Completed

Phase 1

A Double-Blind, Placebo-Controlled, SIngle Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-7746 in Healthy Adult Subjects

Ono Pharmaceutical Co. Ltd1 site in 1 country48 target enrollmentAugust 2009

ConditionsHealthy Adult Subjects

InterventionsONO-7746

Overview

Phase: Phase 1
Intervention: ONO-7746
Conditions: Healthy Adult Subjects
Sponsor: Ono Pharmaceutical Co. Ltd
Enrollment: 48
Locations: 1
Primary Endpoint: Safety and tolerability of ONO-7746 across ascending single doses
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this study is to evaluate the safety and tolerability of ONO-7746 in healthy adult subjects. The secondary objectives are to characterize the pharmacokinetic and pharmacodynamic profiles of ONO-7746.

Registry

clinicaltrials.gov

Start Date

August 2009

End Date

March 2010

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ono Pharmaceutical Co. Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy non-smoking male or female subjects (18-55 years inclusive)
•Body mass index (BMI) of 19-35 kg/m² (inclusive)
•For females: postmenopausal, non-lactating and non-pregnant

Exclusion Criteria

•History or presence of clinically significant disease

Arms & Interventions

P

Intervention: ONO-7746

E

Intervention: ONO-7746

Outcomes

Primary Outcomes

Safety and tolerability of ONO-7746 across ascending single doses

Time Frame: study duration

Secondary Outcomes

Characterization of PK and PD profiles of ONO-7746(study duration)

Study Sites (1)

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