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

NCT00580190 | Terminated Phase 1

• 1 other identifier: A8821006
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Area under the cortisol concentration time curve from 0 to 3 hours ( AUC(0-3) ) following naloxone challenge

  1st day on treatment

Secondary Outcomes (6)

• 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)

Study Arms (3)

1

ACTIVE COMPARATOR

Drug: alprazolam

2

PLACEBO COMPARATOR

Other: Placebo

3

EXPERIMENTAL

Drug: PF-00572778

Interventions

alprazolam DRUG

tablet, 0.5 mg, single dose, only on Day 7 of the study

1

Placebo OTHER

solution, matching placebo to 500 mg PF-00572778, single dose, Days 1 and 7 of the study

2

PF-00572778 DRUG

solution, 500 mg, single dose, only on Day 7 of the study

3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Interventions

Alprazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 24, 2007
• Study Start: September 1, 2007
• Study Completion: February 1, 2008
• Last Updated: September 14, 2009

Record last verified: 2009-09

Locations

US (1)