Study Evaluating Oral MOA-728 in Subjects on Methadone Th... | NCT00505583

Studies
Study Evaluating Oral MOA-728 in Subjects on Methadone Therapy

NCT00505583

Sponsor

Bausch Health Americas, Inc.

Status

Withdrawn

Last Update Posted

Nov 29, 2019Actual

Enrollment

0Actual

Phase

Phase 1

Conditions

Methadone-maintenance Subjects

Interventions

MOA-728

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

Nov 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Jul 2007

Primary Completion Date

Dec 2007Estimated

Completion Date

Dec 2007Estimated

First Submitted Date

Jul 16, 2007

First Submission Date that Met QC Criteria

Jul 20, 2007

First Posted Date

Jul 23, 2007Estimated

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

Nov 26, 2019

Last Update Posted Date

Nov 29, 2019Actual

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

0Actual

Name	Type	Description	Arm Group Labels	Other Names
MOA-728	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To characterize the pharmacodynamics of single oral doses of MOA-728 compared to a positive control of MOA-728 administered intravenously in subjects on stable methadone maintenance.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion:

Healthy men or women, aged 18 to 65 years.
History of methadone treatment for at least 1 month, at a dose >=30 and <=140 mg/day.

Exclusion:

History or active presence of clinically important medical disease.
Allergy to opioids.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeff Cohn	Bausch Health Americas, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Gainesville	Florida	32608	United States