Safety and Tolerability of Retinoid QLT091001 in Healthy Volunteers

This study is currently recruiting participants.

Verified by QLT Inc, October 2008

Sponsored by:	QLT Inc
Information provided by:	QLT Inc
ClinicalTrials.gov Identifier:	NCT00765427

Purpose

Healthy volunteer subjects will receive retinoid QLT091001 once-daily for 7 days for safety observation.

Condition	Intervention	Phase
Healthy Human Volunteers	Drug: QLT091001	Phase I

Study Type:	Interventional
Study Design:	Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Phase 1a, Repeat-Dose Escalation Study to Investigate the Safety and Tolerability of a 7-Day Repeated Dose of Retinoid QLT091001 in Healthy Volunteers

Further study details as provided by QLT Inc:

Primary Outcome Measures:

Clinical laboratory tests, ECG, vital signs, color vision, and visual acuity [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Estimated Enrollment:	18
Study Start Date:	September 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Intervention Details:

7-day repeated dose

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00765427

Contacts

Contact: Mary Moore, MD

519-685-8312

Locations

Sponsors and Collaborators

QLT Inc

Investigators

Principal Investigator:	Victor Lao, MD	Unaffiliated
Study Director:	Andrew Strong, Ph.D.	QLT Inc

More Information

Responsible Party:	QLT Inc. ( Sue-Anne Crocker )
Study ID Numbers:	RET HV 01
Study First Received:	September 30, 2008
Last Updated:	October 1, 2008
ClinicalTrials.gov Identifier:	NCT00765427
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 13, 2009