Safety and Tolerability of Retinoid QLT091001 in Healthy... | NCT00765427

Studies
Safety and Tolerability of Retinoid QLT091001 in Healthy Volunteers

NCT00765427

Sponsor

QLT Inc.

Status

Completed

Last Update Posted

Mar 30, 2009Estimated

Enrollment

18Estimated

Phase

Phase 1

Conditions

Healthy Human Volunteers

Interventions

QLT091001

Countries

Canada

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

Mar 2009

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

Sep 2008

Primary Completion Date

Mar 2009Actual

Completion Date

Mar 2009Actual

First Submitted Date

Sep 30, 2008

First Submission Date that Met QC Criteria

Oct 1, 2008

First Posted Date

Oct 3, 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

Mar 27, 2009

Last Update Posted Date

Mar 30, 2009Estimated

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

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

18Estimated

Name	Type	Description	Arm Group Labels	Other Names
QLT091001	Drug	7-day repeated dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical laboratory tests, ECG, vital signs, color vision, and visual acuity		30 days

Secondary Outcomes

Measure	Description	Time Frame
Adverse events		30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy subjects with ECG within normal limits and normal blood pressure and resting heart rate

Exclusion Criteria:

Subjects with any clinically important abnormal physical finding at screening.
Subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 60 days of baseline.
Female subjects who are either pregnant or lactating.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Victor Lao, MD		Principal Investigator
Andrew Strong, Ph.D.	QLT Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Toronto	Ontario		Canada

Intervention Browse Module

MeSH Terms

ID	Term
C009166	retinol acetate

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided