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Safety and Tolerability of Retinoid QLT091001 in Healthy Volunteers

This study has been completed.
Information provided by:
QLT Inc. Identifier:
First received: September 30, 2008
Last updated: March 27, 2009
Last verified: March 2009
Healthy volunteer subjects will receive retinoid QLT091001 once-daily for 7 days for safety observation.

Condition Intervention Phase
Healthy Human Volunteers Drug: QLT091001 Phase 1

Study Type: Interventional
Study Design: 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

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 ]

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

Estimated Enrollment: 18
Study Start Date: September 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: QLT091001
    7-day repeated dose

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00765427

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

Responsible Party: Sue-Anne Crocker, QLT Inc. Identifier: NCT00765427     History of Changes
Other Study ID Numbers: RET HV 01
Study First Received: September 30, 2008
Last Updated: March 27, 2009

Additional relevant MeSH terms:
Retinol acetate
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Anticarcinogenic Agents
Protective Agents
Antineoplastic Agents processed this record on September 25, 2017