ONO-7746 Study in Healthy Adult Subjects

Phase 1

Completed

• Conditions: Healthy Adult Subjects
• Interventions: Drug: ONO-7746

• Registration Number: NCT00956371
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-10
• Study First Submitted QC: 2009-08-10
• Study First Posted: 2009-08-11
• Primary Completion: 2010-03
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-12
• Last Update Posted: 2012-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
P	ONO-7746	-
E	ONO-7746	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of ONO-7746 across ascending single doses	study duration

Secondary Outcome Measures

Name	Time	Method
Characterization of PK and PD profiles of ONO-7746	study duration

Trial Locations

Locations (1)

Austin; 🇺🇸 Austin, Texas, United States