Safety and Tolerability of ACU-4429 | NCT00703183

Studies
Safety and Tolerability of ACU-4429

NCT00703183

Sponsor

Kubota Vision Inc.

Status

Completed

Last Update Posted

Jun 27, 2012Estimated

Enrollment

46Actual

Phase

Phase 1

Conditions

Healthy

Interventions

ACU-4429
matching placebo

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

May 2008

Primary Completion Date

Jun 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

Jun 19, 2008

First Submission Date that Met QC Criteria

Jun 20, 2008

First Posted Date

Jun 23, 2008Estimated

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 25, 2012

Last Update Posted Date

Jun 27, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of a new investigational drug (ACU-4429) in healthy human volunteers.

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

46Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	ACU-4429	Drug: ACU-4429
2	Placebo Comparator	matching placebo	Drug: matching placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ACU-4429	Drug	administered as a single dose, orally	1
matching placebo

Measure	Description	Time Frame
Safety and tolerability		7 days

Measure	Description	Time Frame
Pharmacokinetics		2 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Is male or female with age ≥ 55 and ≤ 80 years at the time of consent
Is healthy as determined by medical history and physical examination

Exclusion Criteria:

Is receiving or has recently received treatment with a medication disallowed per the protocol

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

80 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
William W Lewis, M.D.	Covance	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Covance Clinical Research Unit, Inc		Dallas	Texas	75247	United States

Intervention Browse Module

MeSH Terms

ID	Term
C000592692	emixustat

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided