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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.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Placebo Comparator |
| |
| 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alprazolam | Drug | tablet, 0.5 mg, single dose, only on Day 7 of the study |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the cortisol concentration time curve from 0 to 3 hours ( AUC(0-3) ) following naloxone challenge | 1st day on treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | New Haven | Connecticut | 06511 | United States |
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| ID | Term |
|---|---|
| D000525 | Alprazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Placebo |
| Other |
solution, matching placebo to 500 mg PF-00572778, single dose, Days 1 and 7 of the study |
|
| PF-00572778 | Drug | solution, 500 mg, single dose, only on Day 7 of the study |
|
| 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 |
| D006571 | Heterocyclic Compounds |