Safety and Tolerability of Retinoid QLT091001 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Human Volunteers

• Registration Number: NCT00765427
• Lead Sponsor: QLT Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-30
• Study First Submitted QC: 2008-10-01
• Study First Posted: 2008-10-03
• Status Verified: 2009-03
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Last Update Submitted: 2009-03-27
• Last Update Posted: 2009-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Clinical laboratory tests, ECG, vital signs, color vision, and visual acuity	30 days

Secondary Outcome Measures

Name	Time	Method
Adverse events	30 days