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
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 April 16, 2014