ONO-7746 Study in Healthy Adult Subjects | NCT00956371

Studies
ONO-7746 Study in Healthy Adult Subjects

NCT00956371

Sponsor

Ono Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Jun 14, 2012Estimated

Enrollment

48Actual

Phase

Phase 1

Conditions

Healthy Adult Subjects

Interventions

ONO-7746
ONO-7746

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Mar 2010Actual

Completion Date

Not provided

First Submitted Date

Aug 10, 2009

First Submission Date that Met QC Criteria

Aug 10, 2009

First Posted Date

Aug 11, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2012

Last Update Posted Date

Jun 14, 2012Estimated

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
P	Placebo Comparator		Drug: ONO-7746
E	Experimental		Drug: ONO-7746

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ONO-7746	Drug	5mg, 10mg, 20mg, 50mg, 100mg, 200mg, 400mg, 800mg, 1200mg QD/1 day	P

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and tolerability of ONO-7746 across ascending single doses		study duration

Secondary Outcomes

Measure	Description	Time Frame
Characterization of PK and PD profiles of ONO-7746		study duration

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ono Pharma USA, Inc.	Ono Pharmaceutical Co., Ltd.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Austin		Austin	Texas	78744	United States