Safety and Tolerability of Retinoid QLT091001 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00765427
Recruitment Status : Completed
First Posted : October 3, 2008
Last Update Posted : March 30, 2009
Information provided by:
QLT Inc.

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

Condition or disease Intervention/treatment Phase
Healthy Human Volunteers Drug: QLT091001 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
Study Start Date : September 2008
Primary Completion Date : March 2009
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: QLT091001
    7-day repeated dose

Primary Outcome Measures :
  1. Clinical laboratory tests, ECG, vital signs, color vision, and visual acuity [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00765427

Canada, Ontario
Toronto, Ontario, Canada
Sponsors and Collaborators
QLT Inc.
Principal Investigator: Victor Lao, MD
Study Director: Andrew Strong, Ph.D. QLT Inc.

Responsible Party: Sue-Anne Crocker, QLT Inc. Identifier: NCT00765427     History of Changes
Other Study ID Numbers: RET HV 01
First Posted: October 3, 2008    Key Record Dates
Last Update Posted: March 30, 2009
Last Verified: March 2009

Additional relevant MeSH terms:
Retinol acetate
Vitamin A
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Anticarcinogenic Agents
Protective Agents
Antineoplastic Agents
Growth Substances