Evaluation Of PF-00572778 And Alprazolam On Naloxone Challenge In Healthy Subjects
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: alprazolam Other: Placebo Drug: PF-00572778 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 47 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
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 |
Study Start Date : | September 2007 |
Actual Study Completion Date : | February 2008 |
Arm | Intervention/treatment |
---|---|
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
|
- Area under the cortisol concentration time curve from 0 to 3 hours ( AUC(0-3) ) following naloxone challenge [ 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 ]
- 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 ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00580190
United States, Connecticut | |
Pfizer Investigational Site | |
New Haven, Connecticut, United States, 06511 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer Inc |
ClinicalTrials.gov Identifier: | NCT00580190 History of Changes |
Other Study ID Numbers: |
A8821006 |
First Posted: | December 24, 2007 Key Record Dates |
Last Update Posted: | September 14, 2009 |
Last Verified: | September 2009 |
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 |