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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00765427
Other study ID # RET HV 01
Secondary ID
Status Completed
Phase Phase 1
First received September 30, 2008
Last updated March 27, 2009
Start date September 2008
Est. completion date March 2009

Study information

Verified date March 2009
Source QLT Inc.
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date March 2009
Est. primary completion date March 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 60 Years
Eligibility 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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Drug:
QLT091001
7-day repeated dose

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
QLT Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical laboratory tests, ECG, vital signs, color vision, and visual acuity 30 days Yes
Secondary Adverse events 30 days Yes
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