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

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE December 20, 2007
First Posted Date  ICMJE December 24, 2007
Last Update Posted Date September 14, 2009
Study Start Date  ICMJE September 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2008)
Area under the cortisol concentration time curve from 0 to 3 hours ( AUC(0-3) ) following naloxone challenge [ Time Frame: 1st day on treatment ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
Area under the cortisol concentration time curve from 0 to 3 hours ( AUC(0-3) ) following naloxone challenge [ Time Frame: 1st day on treatemnt ]
Change History Complete list of historical versions of study NCT00580190 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2008)
  • 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 ]
  • Safety laboratory tests, vital signs, ECGs, adverse events monitoring, and physical<br>examinations [ Time Frame: 34 days (weekly) ]
  • Peak concentrations for plasma cortisol and ACTH [ 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) ]
  • Area under the ACTH concentration curve from 0 to 3 hours ( AUC(0-3) ) following naloxone challenge [ Time Frame: 1st day on treatment ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
  • 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<br>examinations [ Time Frame: 34 days (weekly) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation Of PF-00572778 And Alprazolam On Naloxone Challenge In Healthy Subjects
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: 1
    Intervention: Drug: alprazolam
  • Placebo Comparator: 2
    Intervention: Other: Placebo
  • Experimental: 3
    Intervention: Drug: PF-00572778
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 18, 2008)
47
Original Estimated Enrollment  ICMJE
 (submitted: December 20, 2007)
60
Actual Study Completion Date  ICMJE February 2008
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00580190
Other Study ID Numbers  ICMJE A8821006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2009

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