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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00580190
• Other study ID #: A8821006
• Status: Terminated
• Phase: Phase 1
• First received: December 20, 2007
• Last updated: September 11, 2009
• Start date: September 2007
• Est. completion date: February 2008

Study information

• Verified date: September 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 47
• Est. completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the cortisol concentration time curve from 0 to 3 hours ( AUC(0-3) ) following naloxone challenge		1st day on treatment	No
Secondary	Maximum observed serum concentration (Cmax)		1st day on treatment	No
Secondary	Time to reach the maximum observed serum concentration (Tmax)		1st day on treatment	No
Secondary	Safety laboratory tests, vital signs, ECGs, adverse events monitoring, and physical<br>examinations		34 days (weekly)	Yes
Secondary	Peak concentrations for plasma cortisol and ACTH		1st day on treatment	No
Secondary	Area under the concentration-time curve from time = 0 to time of the last quantifiable serum PF-00572778 concentration (AUClast)		2nd day on treatment (Days 6-7)	No
Secondary	Area under the ACTH concentration curve from 0 to 3 hours ( AUC(0-3) ) following naloxone challenge		1st day on treatment	No

External Links

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