Safety and Tolerability of Retinoid QLT091001 in Healthy Volunteers

Healthy Human Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00765427
• Other study ID #: RET HV 01
• 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

• Healthy Human Volunteers

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