Study Evaluating the Safety of MOA-728 Administered Orall... | NCT00311350

Studies
Study Evaluating the Safety of MOA-728 Administered Orally to Healthy Subjects

NCT00311350

Sponsor

Bausch Health Americas, Inc.

Status

Completed

Last Update Posted

Nov 25, 2019Actual

Enrollment

Phase

Phase 1

Conditions

Postoperative Complications
Constipation

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

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Mar 2006

Primary Completion Date

Not provided

Completion Date

Aug 2006

First Submitted Date

Apr 3, 2006

First Submission Date that Met QC Criteria

Apr 3, 2006

First Posted Date

Apr 5, 2006Estimated

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 21, 2019

Last Update Posted Date

Nov 25, 2019Actual

Description Module

Brief Summary

This is the first multiple-dose experience in humans with MOA-728 in an oral formulation. This study will provide an assessment of the safety, tolerability, and pharmacokinetics (PK) of MOA-728 following administration of ascending multiple oral doses to healthy subjects.

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

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

Measure	Description	Time Frame
Safety

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy men and women

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

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
		Philadelphia	Pennsylvania	19148	United States

Condition Browse Module

MeSH Terms

ID	Term
D011183	Postoperative Complications
D003248	Constipation
D045823	Ileus

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided