Official Title: “A Phase 1, Randomized, Fixed Sequence Study To Evaluate The Effect Of Multiple Dose Administration Of Modified Release Diltiazem On The Multiple Dose Pharmacokinetics Of CP-945,598 In Healthy Overweight And Obese Subjects”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study

Intervention(s) in this Clinical Trial

• Drug: CP-945,598
  • 20 mg CP-945,598 + 240 mg MR Diltiazem
• Drug: CP-945,598
  • 20 mg CP-945,598 alone

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Group A
• Experimental: Group B

Primary Measures

• Pharmacokinetic parameters of CP-945,598 and its metabolite, CE-156,706, (AUCtau, Cmax and Tmax)
  • Time Frame: Days 7 and 28
    Safety Issue?: No
• Safety endpoints including adverse event monitoring, physical examinations, vital signs, ECGs, and clinical laboratory tests.
  • Time Frame: 28 days
    Safety Issue?: No

Inclusion Criteria:

• No clinically relevant abnormalities based upon medical history, physical exam, 12-lead ECG, and clinical lab tests
• Body Mass Index (BMI) ~ 27-40 kg/m2, inclusive
• Personally signed inform consent document

Exclusion Criteria:

• Evidence or history of significant acute or chronic disease
• Pregnant or nursing females
• Screening PR interval > 220 msec
• Sitting blood pressure <= 90 mmHg systolic or <= 60 mmHg diastolic

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00645463

Study ID Number: A5351043

ClinicalTrials.gov Identifier: NCT00645463

Health Authority: United States: Food and Drug Administration

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