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:

Drug Information available for: Alprazolam

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<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
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Anti-Anxiety Agents Central Nervous System Agents Central Nervous System Depressants GABA Agents GABA Modulators Hypnotics and Sedatives	Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Pharmacologic Actions Physiological Effects of Drugs Psychotropic Drugs Therapeutic Uses Tranquilizing Agents

ClinicalTrials.gov processed this record on February 27, 2015

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