Safety and Tolerability of Retinoid QLT091001 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
QLT Inc.
ClinicalTrials.gov Identifier:
NCT00765427
First received: September 30, 2008
Last updated: March 27, 2009
Last verified: March 2009
  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 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

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
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
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 ClinicalTrials.gov identifier: NCT00765427

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

No publications provided

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

ClinicalTrials.gov processed this record on October 29, 2014