Evaluation Of PF-00572778 And Alprazolam On Naloxone Challenge In Healthy Subjects
Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy People
Intervention: alprazolam (Drug); Placebo (Other); PF-00572778 (Drug)
Phase: Phase 1
Status: Terminated
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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.
Clinical Details
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 design: Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Pharmacodynamics Study
Primary outcome: Area under the cortisol concentration time curve from 0 to 3 hours ( AUC(0-3) ) following naloxone challenge
Secondary outcome: Maximum observed serum concentration (Cmax)Time to reach the maximum observed serum concentration (Tmax) Safety laboratory tests, vital signs, ECGs, adverse events monitoring, and physical examinations Peak concentrations for plasma cortisol and ACTH Area under the concentration-time curve from time = 0 to time of the last quantifiable serum PF-00572778 concentration (AUClast) Area under the ACTH concentration curve from 0 to 3 hours ( AUC(0-3) ) following naloxone challenge
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Pfizer Investigational Site, New Haven, Connecticut 06511, United States
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: September 2007
Ending date: February 2008
Last updated: April 18, 2008
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