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

Pfizer

Status and phase: Terminated; Phase 1

Conditions: Healthy

Treatments: Drug: alprazolam; Other: Placebo; Drug: PF-00572778

Study type: Interventional

Funder types: Industry

Identifiers

NCT00580190

A8821006

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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47 participants in 3 patient groups, including a placebo group

1

Active Comparator group

Treatment:

Drug: alprazolam

2

Placebo Comparator group

Treatment:

Other: Placebo

3

Experimental group

Treatment:

Drug: PF-00572778