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

This study has been 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.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00580190
First received: December 20, 2007
Last updated: September 11, 2009
Last verified: September 2009
History of Changes
  Purpose

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 Intervention Phase
Healthy
 Drug: alprazolam
Other: Placebo
Drug: PF-00572778
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Area under the cortisol concentration time curve from 0 to 3 hours ( AUC(0-3) ) following naloxone challenge [ Time Frame: 1st day on treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum observed serum concentration (Cmax) [ Time Frame: 1st day on treatment ] [ Designated as safety issue: No ]
  • Time to reach the maximum observed serum concentration (Tmax) [ Time Frame: 1st day on treatment ] [ Designated as safety issue: No ]
  • Safety laboratory tests, vital signs, ECGs, adverse events monitoring, and physical examinations [ Time Frame: 34 days (weekly) ] [ Designated as safety issue: Yes ]
  • Peak concentrations for plasma cortisol and ACTH [ Time Frame: 1st day on treatment ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Area under the ACTH concentration curve from 0 to 3 hours ( AUC(0-3) ) following naloxone challenge [ Time Frame: 1st day on treatment ] [ Designated as safety issue: No ]

Enrollment: 47
Study Start Date: September 2007
Study Completion Date: February 2008
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00580190

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

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00580190     History of Changes
Other Study ID Numbers: A8821006
Study First Received: December 20, 2007
Last Updated: September 11, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alprazolam
Naloxone
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Anxiety Agents
 Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Narcotic Antagonists
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013