Safety and Tolerability of Retinoid QLT091001 in Healthy Volunteers

March 27, 2009 updated by: QLT Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical laboratory tests, ECG, vital signs, color vision, and visual acuity
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

QLT Inc.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

September 30, 2008

First Submitted That Met QC Criteria

October 1, 2008

First Posted (Estimate)

October 3, 2008

Study Record Updates

Last Update Posted (Estimate)

March 30, 2009

Last Update Submitted That Met QC Criteria

March 27, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RET HV 01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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