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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

December 20, 2007
September 11, 2009
September 2007
Not Provided
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 ]
Area under the cortisol concentration time curve from 0 to 3 hours ( AUC(0-3) ) following naloxone challenge [ Time Frame: 1st day on treatemnt ]
Complete list of historical versions of study NCT00580190 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Area under the ACTH concentration curve from 0 to 3 hours ( AUC(0-3) ) following naloxone challenge [ Time Frame: 1st day on treatment ]
  • Peak concentrations for plasma cortisol and ACTH [ Time Frame: 1st day on treatment ]
  • Maximum observed serum concentration (Cmax) [ Time Frame: 1st day on treatment ]
  • Time to reach the maximum observed serum concentration (Tmax) [ Time Frame: 1st day on treatment ]
  • 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) ]
  • Safety laboratory tests, vital signs, ECGs, adverse events monitoring, and physical examinations [ Time Frame: 34 days (weekly) ]
Not Provided
Not Provided
 
Evaluation Of PF-00572778 And Alprazolam On Naloxone Challenge In Healthy Subjects
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

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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Healthy
  • Drug: alprazolam
    tablet, 0.5 mg, single dose, only on Day 7 of the study
  • Other: Placebo
    solution, matching placebo to 500 mg PF-00572778, single dose, Days 1 and 7 of the study
  • Drug: PF-00572778
    solution, 500 mg, single dose, only on Day 7 of the study
  • Active Comparator: 1
    Intervention: Drug: alprazolam
  • Placebo Comparator: 2
    Intervention: Other: Placebo
  • Experimental: 3
    Intervention: Drug: PF-00572778
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
47
February 2008
Not Provided

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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00580190
A8821006
No
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP