NCT00645463

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1 obesity

Timeline
Completed

Started Mar 2007

Shorter than P25 for phase_1 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 27, 2008

Completed
Last Updated

September 17, 2009

Status Verified

March 1, 2008

First QC Date

March 21, 2008

Last Update Submit

September 16, 2009

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetic parameters of CP-945,598 and its metabolite, CE-156,706, (AUCtau, Cmax and Tmax)

    Days 7 and 28

  • Safety endpoints including adverse event monitoring, physical examinations, vital signs, ECGs, and clinical laboratory tests.

    28 days

Study Arms (2)

Group A

EXPERIMENTAL
Drug: CP-945,598

Group B

EXPERIMENTAL
Drug: CP-945,598

Interventions

CP-945,598DRUG

20 mg CP-945,598 + 240 mg MR Diltiazem

Group A

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Ann Arbor, Michigan, 48105, United States

Location

Related Links

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 21, 2008

First Posted

March 27, 2008

Study Start

March 1, 2007

Study Completion

June 1, 2007

Last Updated

September 17, 2009

Record last verified: 2008-03

Locations

US(1)