NCT00813670

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 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

November 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 23, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

September 14, 2009

Status Verified

September 1, 2009

Enrollment Period

6 months

First QC Date

December 19, 2008

Last Update Submit

September 10, 2009

Conditions

Healthy Human Volunteers

Outcome Measures

Primary Outcomes (1)

  • ECGs, Telemetry, Vital Signs, Physical Examinations, Laboratory Assessments and Adverse Events.

    up to 14 days post dose

Study Arms (8)

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

Interventions

XPF-001DRUG

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

Cohort 1: Single dose of XPF-001Cohort 2: Single dose of XPF-001Cohort 3: Single dose of XPF-001Cohort 4: Single dose of XPF-001Cohort 5: Single dose of XPF-001Cohort A: Repeated doses of XPF-001Cohort B: Repeated doses of XPF-001Cohort C: Repeated doses of XPF-001

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anapharm

Montreal, Quebec, Canada

Location

Study Officials

  • Richard Larouche, MD

    Anapharm

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 19, 2008

First Posted

December 23, 2008

Study Start

November 1, 2008

Primary Completion

May 1, 2009

Study Completion

July 1, 2009

Last Updated

September 14, 2009

Record last verified: 2009-09

Locations

CA(1)