Trial | NCT00813670  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    xpf-001 ...

  • Study Participants

    64
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 Started
Nov 30
2008
Primary Completion
May 31
2009
Study Completion
Jul 31
2009
Last Update
Sep 14
2009
Estimate

Drug XPF-001

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

Cohort 1: Single dose of XPF-001 Experimental

Cohort 2: Single dose of XPF-001 Experimental

Cohort 3: Single dose of XPF-001 Experimental

Cohort 4: Single dose of XPF-001 Experimental

Cohort 5: Single dose of XPF-001 Experimental

Cohort A: Repeated doses of XPF-001 Experimental

Cohort B: Repeated doses of XPF-001 Experimental

Cohort C: Repeated doses of XPF-001 Experimental

Criteria 

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
No Results Posted