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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00813670

Enrollment

Registered

2008-12-23

Start date

2008-11-30

Completion date

2009-07-31

Last updated

2009-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Human Volunteers

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.

Interventions

DRUGXPF-001

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
ECGs, Telemetry, Vital Signs, Physical Examinations, Laboratory Assessments and Adverse Events.	up to 14 days post dose

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026