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

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: alprazolam; Other: Placebo; Drug: PF-00572778	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	47 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Treatment
Official Title:	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
Study Start Date :	September 2007
Actual Study Completion Date :	February 2008

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: 1	Drug: alprazolam; tablet, 0.5 mg, single dose, only on Day 7 of the study
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

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Maximum observed serum concentration (Cmax) [ Time Frame: 1st day on treatment ]
2. Time to reach the maximum observed serum concentration (Tmax) [ Time Frame: 1st day on treatment ]
3. Safety laboratory tests, vital signs, ECGs, adverse events monitoring, and physical<br>examinations [ Time Frame: 34 days (weekly) ]
4. Peak concentrations for plasma cortisol and ACTH [ Time Frame: 1st day on treatment ]
5. 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) ]
6. Area under the ACTH concentration curve from 0 to 3 hours ( AUC(0-3) ) following naloxone challenge [ Time Frame: 1st day on treatment ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

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Locations

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

Sponsors and Collaborators

Pfizer

Investigators

Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier:	NCT00580190 History of Changes
Other Study ID Numbers:	A8821006
First Posted:	December 24, 2007
Last Update Posted:	September 14, 2009
Last Verified:	September 2009

Additional relevant MeSH terms:

Naloxone; Alprazolam; Narcotic Antagonists; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Hypnotics and Sedatives; Central Nervous System Depressants	Anti-Anxiety Agents; Tranquilizing Agents; Psychotropic Drugs; GABA Modulators; GABA Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action