Healthy Human VolunteersPhase 1NCT00813670
Single and Multiple Ascending Dose Safety Study of XPF-001 in Healthy Volunteers
A Phase 1 study testing XPF-001 in people with Healthy Human Volunteers, run by Xenon Pharmaceuticals Inc. at 1 site in Canada.
Trial summary
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of single and multiple doses of XPF-001 in healthy volunteers. The effect of food on the pharmacokinetics of XPF-001 will also be studied. 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?
- XPF-001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2008to Jul 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 (Females of non-childbearing potential) with normal or clinically insignificant laboratory results, ECGs and physical examinations.
Who cannot join
- Subjects with a presence or history of any clinically significant disease.
- Subjects who have participated in and investigational drug trial within 60 days of admission.
- Subjects who have used tobacco or nictoine products in the 1 month prior to admission
- Females who are pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of XPF-001 and to Investigate the Effect of Food on the Pharmacokinetics of a Single Dose of XPF-001 in Healthy Subjects
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of single and multiple doses of XPF-001 in healthy volunteers.
The effect of food on the pharmacokinetics of XPF-001 will also be studied.
- Conditions
- Healthy Human Volunteers
- Being tested
- XPF-001
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XPF-001Drug
Single oral dose, or 6 days of repeated oral doses.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Single dose of XPF-001 | Experimental | Not described Receives: Drug: XPF-001 |
| Cohort 2: Single dose of XPF-001 | Experimental | Not described Receives: Drug: XPF-001 |
| Cohort 3: Single dose of XPF-001 | Experimental | Not described Receives: Drug: XPF-001 |
| Cohort 4: Single dose of XPF-001 | Experimental | Not described Receives: Drug: XPF-001 |
| Cohort 5: Single dose of XPF-001 | Experimental | Not described Receives: Drug: XPF-001 |
| Cohort A: Repeated doses of XPF-001 | Experimental | Not described Receives: Drug: XPF-001 |
| Cohort B: Repeated doses of XPF-001 | Experimental | Not described Receives: Drug: XPF-001 |
| Cohort C: Repeated doses of XPF-001 | Experimental | Not described Receives: Drug: XPF-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ECGs, Telemetry, Vital Signs, Physical Examinations, Laboratory Assessments and Adverse Events.
Measured: up to 14 days post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionMay 2009
- Study completionJul 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xenon Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Richard Larouche, MD, Principal investigator, Anapharm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00813670
- Sponsor's protocol ID
- XPF-001-101
- Status last verified
- Sep 2009
- First submitted
- 19 Dec 2008
- Last updated
- 14 Sep 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of XPF-001 and to Investigate the Effect of Food on the Pharmacokinetics of a Single Dose of XPF-001 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00813670
- Acronym / sponsor ID
- XPF-001-101
- Conditions
- Healthy Human Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Xenon Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 23 Dec 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.
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of single and multiple doses of XPF-001 in healthy volunteers.
The effect of food on the pharmacokinetics of XPF-001 will also be studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Single dose of XPF-001 | Experimental | Drug: XPF-001 |
| Cohort 2: Single dose of XPF-001 | Experimental | Drug: XPF-001 |
| Cohort 3: Single dose of XPF-001 | Experimental | Drug: XPF-001 |
| Cohort 4: Single dose of XPF-001 | Experimental | Drug: XPF-001 |
| Cohort 5: Single dose of XPF-001 | Experimental | Drug: XPF-001 |
| Cohort A: Repeated doses of XPF-001 | Experimental | Drug: XPF-001 |
| Cohort B: Repeated doses of XPF-001 | Experimental | Drug: XPF-001 |
| Cohort C: Repeated doses of XPF-001 | Experimental | Drug: XPF-001 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy subjects (Females of non-childbearing potential) with normal or clinically insignificant laboratory results, ECGs and physical examinations.
Key exclusion criteria (4 listed)
- Subjects with a presence or history of any clinically significant disease.
- Subjects who have participated in and investigational drug trial within 60 days of admission.
- Subjects who have used tobacco or nictoine products in the 1 month prior to admission
- Females who are pregnant or breastfeeding
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 |
|---|---|---|
| XPF-001Single oral dose, or 6 days of repeated oral doses. | Drug | Cohort 1: Single dose of XPF-001, Cohort 2: Single dose of XPF-001, Cohort 3: Single dose of XPF-001, Cohort 4: Single dose of XPF-001, Cohort 5: Single dose of XPF-001, Cohort A: Repeated doses of XPF-001, Cohort B: Repeated doses of XPF-001, Cohort C: Repeated doses of XPF-001 |
Primary outcome
ECGs, Telemetry, Vital Signs, Physical Examinations, Laboratory Assessments and Adverse Events.
Time frame: up to 14 days post dose
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 14 Sep 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.
Richard Larouche, MD principal investigator
Anapharm
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 XPF-001 in people with Healthy Human Volunteers, run by Xenon Pharmaceuticals 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 4 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 14 Sep 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?
ECGs, Telemetry, Vital Signs, Physical Examinations, Laboratory Assessments and Adverse Events. (time frame: up to 14 days post dose). 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 14 Sep 2009.