ONO-7746 Study in Healthy Adult Subject

Sponsor

Ono Pharmaceutical Co. Ltd (Industry)

Overall Status

Completed

CT.gov ID

NCT01106664

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Adult Subjects	Drug: ONO-7746 Drug: ONO-7746	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2010

Actual Primary Completion Date :

Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: P	Drug: ONO-7746 1mg, 2mg, 4mg, 8mg, 16mg, once daily for multiple-dose study; 4mg at a single dose for food effect study.
Experimental: E	Drug: ONO-7746 1mg, 2mg, 4mg, 8mg, 16mg once daily for multiple-dose study; 4mg at a single dose for food effect study

Arm

Intervention/Treatment

Placebo Comparator: P

Drug: ONO-7746

1mg, 2mg, 4mg, 8mg, 16mg, once daily for multiple-dose study; 4mg at a single dose for food effect study.

Experimental: E

Drug: ONO-7746

1mg, 2mg, 4mg, 8mg, 16mg once daily for multiple-dose study; 4mg at a single dose for food effect study

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Austin Clinical Site	Austin	Texas	United States	78744

Sponsors and Collaborators

Ono Pharmaceutical Co. Ltd

Investigators

Study Director: Ono Pharma USA, Inc., Ono Pharmaceutical Co. Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ono Pharmaceutical Co. Ltd

ClinicalTrials.gov Identifier:

NCT01106664

Other Study ID Numbers:

ONO-7746POU002

First Posted:

Apr 20, 2010

Last Update Posted:

Jun 14, 2012

Last Verified:

Jun 1, 2012

Keywords provided by Ono Pharmaceutical Co. Ltd

ONO-7746

Healthy adult subjects

Study Results

No Results Posted as of Jun 14, 2012