Effect of Diltiazem Administration on CP-945,598 Pharmacokinetics

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00645463
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arms: 2
• Duration (Months): 3
• Patients Per Site Per Month: 9.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Drug: CP-945,598; Drug: CP-945,598	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Mar 1, 2007
• Actual Study Completion Date: Jun 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A	Drug: CP-945,598; 20 mg CP-945,598 + 240 mg MR Diltiazem
Experimental: Group B	Drug: CP-945,598; 20 mg CP-945,598 alone

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetic parameters of CP-945,598 and its metabolite, CE-156,706, (AUCtau, Cmax and Tmax) [Days 7 and 28]

2. Safety endpoints including adverse event monitoring, physical examinations, vital signs, ECGs, and clinical laboratory tests. [28 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Ann Arbor	Michigan	United States	48105

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00645463
• Other Study ID Numbers: A5351043
• First Posted: Mar 27, 2008
• Last Update Posted: Sep 17, 2009
• Last Verified: Mar 1, 2008

Study Results

No Results Posted as of Sep 17, 2009