Evaluation Of PF-00572778 And Alprazolam On Naloxone Challenge In Healthy Subjects

September 11, 2009 updated by: Pfizer

A Phase I, Randomized, Placebo Controlled, Parallel Group, Single Dose Study To Evaluate The Effects Of PF-00572778 And Alprazolam On A Naloxone Challenge In Healthy Adult Subjects

PF-00572778, a CRH antagonist, is expected to attenuate adrenocorticotropin (ACTH) and cortisol responses to naloxone by blocking the effect of the CRH increases induced by naloxone at the postsynaptic receptors. Demonstration of a statistically significant attenuation of naloxone induced increases in cortisol and/or ACTH concentrations by PF-00572778 compared to placebo would thus constitute proof of mechanism for the compound. Therefore, this study is to evaluate pharmacodynamic effects of PF-00572778 following naloxone challenge in healthy subjects.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Healthy male and/or female subjects between the ages of 18 and 45 years; Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria:

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease; Family (1st degree relatives) and personal history of meeting Diagnostic and Statistical Manual -IV (DSM-IV) criteria for alcohol abuse or dependence.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Other: Placebo
solution, matching placebo to 500 mg PF-00572778, single dose, Days 1 and 7 of the study
Experimental: 3
Drug: PF-00572778
solution, 500 mg, single dose, only on Day 7 of the study
Active Comparator: 1
Drug: alprazolam
tablet, 0.5 mg, single dose, only on Day 7 of the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the cortisol concentration time curve from 0 to 3 hours ( AUC(0-3) ) following naloxone challenge
Time Frame: 1st day on treatment
1st day on treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximum observed serum concentration (Cmax)
Time Frame: 1st day on treatment
1st day on treatment
Time to reach the maximum observed serum concentration (Tmax)
Time Frame: 1st day on treatment
1st day on treatment
Safety laboratory tests, vital signs, ECGs, adverse events monitoring, and physical
examinations
Time Frame: 34 days (weekly)
34 days (weekly)
Peak concentrations for plasma cortisol and ACTH
Time Frame: 1st day on treatment
1st day on treatment
Area under the concentration-time curve from time = 0 to time of the last quantifiable serum PF-00572778 concentration (AUClast)
Time Frame: 2nd day on treatment (Days 6-7)
2nd day on treatment (Days 6-7)
Area under the ACTH concentration curve from 0 to 3 hours ( AUC(0-3) ) following naloxone challenge
Time Frame: 1st day on treatment
1st day on treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

December 20, 2007

First Submitted That Met QC Criteria

December 20, 2007

First Posted (Estimate)

December 24, 2007

Study Record Updates

Last Update Posted (Estimate)

September 14, 2009

Last Update Submitted That Met QC Criteria

September 11, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A8821006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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