ONO-7746 Study in Healthy Adult Subject

Phase 1

Completed

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

• Registration Number: NCT01106664
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

Brief Summary

The primary objective of this study is to evaluate the safety and tolerability of NON-7746 in healthy adult subjects. The secondary objectives are to characterize the pharmacokinetic and pharmacodynamic profiles of ONO-7746 and to evaluate the food effect on the PK profile of ONO-7746 when administered with or without a meal.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-13
• Study First Submitted QC: 2010-04-19
• Study First Posted: 2010-04-20
• Primary Completion: 2010-11
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-12
• Last Update Posted: 2012-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Healthy non-smoking male or female subjects (18-55 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
E	ONO-7746	-
P	ONO-7746	-

Primary Outcome Measures

Name	Time	Method
Safety Assessment	up to 42 days	(evaluations of physical examinations, vital signs, 12-lead ECG, slit lamp examinations, safety laboratory tests, and surveillance for adverse events)

Secondary Outcome Measures

Name	Time	Method
Effect of food on ONO-7746 pharmacokinetics	up to 42 days
Characterization of PK and PD profiles, including platelet count changes of ONO-7746	up to 42 days

Trial Locations

Locations (1)

Austin Clinical Site; 🇺🇸 Austin, Texas, United States