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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00580190
Recruitment Status : Terminated (Date of termination was Feb. 7, 2008. Reasons of termination were due to elevation of liver function tests and long elimination half-life of the compound.)
First Posted : December 24, 2007
Last Update Posted : September 14, 2009
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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 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

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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

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 ]

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

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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00580190

United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

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

Additional relevant MeSH terms:
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