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:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00580190
First received: December 20, 2007
Last updated: September 11, 2009
Last verified: September 2009
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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:
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<br>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 (Adult) |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00580190
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:
| 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:
|
Naloxone Alprazolam 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 |
ClinicalTrials.gov processed this record on September 30, 2016