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

Phase 1

Terminated

• Conditions: Healthy
• Interventions: Other: Placebo; Drug: PF-00572778; Drug: alprazolam

• Registration Number: NCT00580190
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2007-12-20
• Study First Posted: 2007-12-24
• Study Completion: 2008-02
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-11
• Last Update Posted: 2009-09-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 47

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	-
3	PF-00572778	-
1	alprazolam	-

Primary Outcome Measures

Name	Time	Method
Area under the cortisol concentration time curve from 0 to 3 hours ( AUC(0-3) ) following naloxone challenge	1st day on treatment

Secondary Outcome Measures

Name	Time	Method
Maximum observed serum concentration (Cmax)	1st day on treatment
Time to reach the maximum observed serum concentration (Tmax)	1st day on treatment
Safety laboratory tests, vital signs, ECGs, adverse events monitoring, and physical<br>examinations	34 days (weekly)
Peak concentrations for plasma cortisol and ACTH	1st day on treatment
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)
Area under the ACTH concentration curve from 0 to 3 hours ( AUC(0-3) ) following naloxone challenge	1st day on treatment

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States