Healthy Human VolunteersPhase 1NCT00765427
Safety and Tolerability of Retinoid QLT091001 in Healthy Volunteers
A Phase 1 study testing QLT091001 in people with Healthy Human Volunteers, run by QLT Inc. at 1 site in Canada.
Trial summary
Healthy volunteer subjects will receive retinoid QLT091001 once-daily for 7 days for safety observation. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Human Volunteers
- What is being tested?
- QLT091001
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2008to Mar 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects with ECG within normal limits and normal blood pressure and resting heart rate
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Healthy volunteer subjects will receive retinoid QLT091001 once-daily for 7 days for safety observation.
- Conditions
- Healthy Human Volunteers
- Being tested
- QLT091001
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLT091001Drug
7-day repeated dose
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical laboratory tests, ECG, vital signs, color vision, and visual acuity
Measured: 30 days
Secondary outcomes (1)
Adverse events
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Human VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- QLT Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Victor Lao, MD, Principal investigatorAndrew Strong, Ph.D., Study director, QLT Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00765427
- Sponsor's protocol ID
- RET HV 01
- Status last verified
- Mar 2009
- First submitted
- 30 Sep 2008
- Last updated
- 30 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00765427
- Acronym / sponsor ID
- RET HV 01
- Conditions
- Healthy Human Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- QLT Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 3 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Healthy volunteer subjects will receive retinoid QLT091001 once-daily for 7 days for safety observation.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy subjects with ECG within normal limits and normal blood pressure and resting heart rate
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QLT0910017-day repeated dose | Drug | – |
Primary outcome
Clinical laboratory tests, ECG, vital signs, color vision, and visual acuity
Time frame: 30 days
1 secondary outcome
Adverse events
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor Lao, MD principal investigator
Andrew Strong, Ph.D. study director
QLT Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing QLT091001 in people with Healthy Human Volunteers, run by QLT Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical laboratory tests, ECG, vital signs, color vision, and visual acuity (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2009.