Effect of Diltiazem Administration on CP-945,598 Pharmacokinetics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2007-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Open Label Study, Assessing the Effect of Diltiazem or Ketoconazole on the Pharmacokinetics of AZD9742 in Healthy Volunteers

NCT01124760

Pharmacokinetics

COMPLETED PHASE1

Pharmacokinetic and Safety Study of Cenicriviroc and HMG-CoA Reductase Inhibitors, Caffeine and Digoxin

NCT02685462

Healthy

COMPLETED PHASE1

A Study of the Effect of Multiple Doses of Diltiazem on the Plasma Levels of MK-6916 in Healthy Participants (MK-6916-005)

NCT06818968

Healthy

COMPLETED PHASE1

A Drug-Drug Interaction Study of Diltiazem and MK-1167 in Healthy Adult Participants (MK-1167-006)

NCT06703463

Healthy

COMPLETED PHASE1

A Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Abiraterone Following Administration of Abiraterone Acetate Tablets in Healthy Adult Men

NCT01588782

Healthy Volunteers

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A

Group Type EXPERIMENTAL

CP-945,598

Intervention Type DRUG

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

Group B

Group Type EXPERIMENTAL

CP-945,598

Intervention Type DRUG

20 mg CP-945,598 alone

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CP-945,598

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

Intervention Type DRUG

CP-945,598

20 mg CP-945,598 alone

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes