NCT00765427

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 3, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

March 30, 2009

Status Verified

March 1, 2009

Enrollment Period

6 months

First QC Date

September 30, 2008

Last Update Submit

March 27, 2009

Conditions

Healthy Human Volunteers

Outcome Measures

Primary Outcomes (1)

  • Clinical laboratory tests, ECG, vital signs, color vision, and visual acuity

    30 days

Secondary Outcomes (1)

  • Adverse events

    30 days

Interventions

QLT091001DRUG

7-day repeated dose

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects with ECG within normal limits and normal blood pressure and resting heart rate

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Toronto, Ontario, Canada

Location

MeSH Terms

Interventions

retinol acetate

Study Officials

  • Victor Lao, MD

    PRINCIPAL INVESTIGATOR

  • Andrew Strong, Ph.D.

    QLT Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 30, 2008

First Posted

October 3, 2008

Study Start

September 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

March 30, 2009

Record last verified: 2009-03

Locations

CA(1)