Safety and Tolerability of Retinoid QLT091001 in Healthy Volunteers
Sponsor
QLT Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00765427
Collaborator
(none)
18
1
5.9
3
Study Details
Study Description
Brief Summary
Healthy volunteer subjects will receive retinoid QLT091001 once-daily for 7 days for safety observation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
18 participants
Allocation:
N/A
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
Study Start Date
:
Sep 1, 2008
Actual Primary Completion Date
:
Mar 1, 2009
Actual Study Completion Date
:
Mar 1, 2009
Outcome Measures
Primary Outcome Measures
- Clinical laboratory tests, ECG, vital signs, color vision, and visual acuity [30 days]
Secondary Outcome Measures
- Adverse events [30 days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 60 Years
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Toronto | Ontario | Canada |
Sponsors and Collaborators
- QLT Inc.
Investigators
- Principal Investigator: Victor Lao, MD,
- Study Director: Andrew Strong, Ph.D., QLT Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00765427
Other Study ID Numbers:
- RET HV 01
First Posted:
Oct 3, 2008
Last Update Posted:
Mar 30, 2009
Last Verified:
Mar 1, 2009
Additional relevant MeSH terms: