Single and Multiple Ascending Dose Safety Study of XPF-001 in Healthy Volunteers

NCT ID: NCT00813670

Last Updated: 2009-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Human Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1: Single dose of XPF-001

Group Type EXPERIMENTAL

XPF-001

Intervention Type DRUG

Single oral dose, or 6 days of repeated oral doses.

Cohort 2: Single dose of XPF-001

Group Type EXPERIMENTAL

XPF-001

Intervention Type DRUG

Single oral dose, or 6 days of repeated oral doses.

Cohort 3: Single dose of XPF-001

Group Type EXPERIMENTAL

XPF-001

Intervention Type DRUG

Single oral dose, or 6 days of repeated oral doses.

Cohort 4: Single dose of XPF-001

Group Type EXPERIMENTAL

XPF-001

Intervention Type DRUG

Single oral dose, or 6 days of repeated oral doses.

Cohort 5: Single dose of XPF-001

Group Type EXPERIMENTAL

XPF-001

Intervention Type DRUG

Single oral dose, or 6 days of repeated oral doses.

Cohort A: Repeated doses of XPF-001

Group Type EXPERIMENTAL

XPF-001

Intervention Type DRUG

Single oral dose, or 6 days of repeated oral doses.

Cohort B: Repeated doses of XPF-001

Group Type EXPERIMENTAL

XPF-001

Intervention Type DRUG

Single oral dose, or 6 days of repeated oral doses.

Cohort C: Repeated doses of XPF-001

Group Type EXPERIMENTAL

XPF-001

Intervention Type DRUG

Single oral dose, or 6 days of repeated oral doses.

Interventions

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XPF-001

Single oral dose, or 6 days of repeated oral doses.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects (Females of non-childbearing potential) with normal or clinically insignificant laboratory results, ECGs and physical examinations.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Xenon Pharmaceuticals Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Xenon

Principal Investigators

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Richard Larouche, MD

Role: PRINCIPAL_INVESTIGATOR

Anapharm

Locations

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Anapharm

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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XPF-001-101

Identifier Type: -

Identifier Source: org_study_id

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