A Phase 1 interventional study of CP-945,598 and CP-945,598 in Obesity, sponsored by Pfizer. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-09-17.
Sponsored by Pfizer · Phase 1, Interventional, and Treatment
A recently completed clinical drug interaction study of CP-945,598 with ketoconazole, a potent CYP3A inhibitor, showed that coadministration of CP-945,598 with ketoconazole results in an approximately 5-fold increase in CP-945,598 total exposure (AUC) and 4-fold increase in Cmax. Therefore, the sensitivity of CP-945,598 pharmacokinetics (PK) to less potent CYP3A inhibitors needs to be characterized to support labeling and registration.
Diltiazem is a known substrate and moderate mechanism-based inhibitor of the CYP3A enzyme system and was chosen as the moderate CYP3A inhibitor for this study as it is a clinically relevant medication likely to be prescribed concomitantly with CP-945,598 given the increased risk of hypertension and cardiovascular disease in the obese patient population.
Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 581 completed or terminated interventional studies of FDA-regulated products, 380 (65%) have results posted.
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Exclusion Criteria:
Drug: CP-945,598
Drug: CP-945,598
20 mg CP-945,598 + 240 mg MR Diltiazem
20 mg CP-945,598 alone
Pharmacokinetic parameters of CP-945,598 and its metabolite, CE-156,706, (AUCtau, Cmax and Tmax)
Time frame: Days 7 and 28
Safety endpoints including adverse event monitoring, physical examinations, vital signs, ECGs, and clinical laboratory tests.
Time frame: 28 days
This study is completed, as verified in Mar 2008. You cannot join it, but the record below documents what was studied.
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