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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Group Type ACTIVE_COMPARATOR

alprazolam

Intervention Type DRUG

tablet, 0.5 mg, single dose, only on Day 7 of the study

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

solution, matching placebo to 500 mg PF-00572778, single dose, Days 1 and 7 of the study

3

Group Type EXPERIMENTAL

PF-00572778

Intervention Type DRUG

solution, 500 mg, single dose, only on Day 7 of the study

Interventions

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alprazolam

tablet, 0.5 mg, single dose, only on Day 7 of the study

Intervention Type DRUG

Placebo

solution, matching placebo to 500 mg PF-00572778, single dose, Days 1 and 7 of the study

Intervention Type OTHER

PF-00572778

solution, 500 mg, single dose, only on Day 7 of the study

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes