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A Multiple Dose Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04457845 in Healthy Volunteers

NCT00836082 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2009-08-06

No results posted yet for this study

Summary

To determine if PF-04457845 at doses of 0.5mg, 1mg, 4mg, and 8 mg given once daily for 14 days will be safe and well tolerated in healthy volunteers. To determine the effect on food on PF-04457845 pharmacokinetics and safety following administration of single doses of 4mg and 8mg.

Conditions

Interventions

DRUG

PF-04457845, FAAH inhibitor

Oral solution of 0.5mg given once daily for 14 days.

DRUG

PF-04457845, FAAH inhibitor

Oral solution of 1mg given once daily for 14 days.

DRUG

PF-04457845, FAAH inhibitor

Oral solution of 4mg will be administered as a single dose 7-14 days prior to the multiple dosing phase where 4mg will be administered once daily for 14 days.

DRUG

PF-04457845, FAAH inhibitor

A randomized food treatment will be administered 7-14 days prior to and on day 1 of the multiple dosing phase

DRUG

PF-04457845, FAAH inhibitor

Oral solution of 8mg will be administered as a single dose 7-14 days prior to the multiple dosing phase where 8mg will be administered once daily for 14 days.

DRUG

PF-04457845, FAAH inhibitor

A randomized food treatment will be administered 7-14 days prior to and on day 1 of the multiple dosing phase

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • Singapore

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00836082 on ClinicalTrials.gov