A Study to Estimate the Effect of CYP3A4 Inhibitors (Itraconazole, Diltiazem or Verapamil) on the Pharmacokinetics of Single Dose PF- 00489791 in Healthy Volunteers

NCT ID: NCT02319148

Last Updated: 2016-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2014-10-31

Brief Summary

The primary objective of the study is to estimate the effects of different strong enzyme (CYP3A4) inhibitors, itraconazole, diltiazem, or verapamil on the single dose pharmacokinetics of PF-00489791 in healthy volunteers. The study will enroll approximately 18 subjects that are randomized to 1 of 3 treatment groups. The study is also intended to determine the safety and tolerability of single-dose PF- 00489791 when it is administered with steady-state itraconazole, diltiazem, or verapamil.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Treatment B

Treatment B subjects receive single dose administration of 20 mg PF-00489791 and multiple dose administration of itraconazole (200 mg once daily).

Group Type: EXPERIMENTAL

itraconazole

Intervention Type: DRUG

itraconazole dosed at 200 mg

PF-00489791

Intervention Type: DRUG

PF-00489791 20 mg single dose administration

Treatment C

Treatment C subjects receive single dose administration of 20 mg PF-00489791 and multiple dose administration of diltiazem (240 mg once daily).

Group Type: EXPERIMENTAL

diltiazem

Intervention Type: DRUG

diltiazem dosed at 240 mg

PF-00489791

Intervention Type: DRUG

PF-00489791 20 mg single dose administration

Treatment D

Treatment D subjects receive single dose administration of 20 mg PF-00489791 and multiple dose administration of verapamil (240 mg once daily).

Group Type: EXPERIMENTAL

SR verapamil

Intervention Type: DRUG

SR verapamil dosed at 240 mg

PF-00489791

Intervention Type: DRUG

PF-00489791 20 mg single dose administration

Interventions

itraconazole

itraconazole dosed at 200 mg

Intervention Type: DRUG

diltiazem

diltiazem dosed at 240 mg

Intervention Type: DRUG

SR verapamil

SR verapamil dosed at 240 mg

Intervention Type: DRUG

PF-00489791

PF-00489791 20 mg single dose administration

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests) with a Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs.) and with a personally signed and dated informed consent document and who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
• Participating female subjects of non-childbearing potential must meet at least one of the following criteria: achieved postmenopausal status; have undergone a documented hysterectomy and/or bilateral oophorectomy; have medically confirmed ovarian failure. All other female subjects (including females with tubal ligations and females that do NOT have a documented hysterectomy, bilateral oophorectomy and/or ovarian failure) will be considered to be of childbearing potential.

Exclusion Criteria

• Subjects cannot be included in the study if there is: the presence/ history of any disorder that prevents study completion
• Evidence/history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
• Any surgical or medical condition that may interfere with the absorption distribution, metabolism, or excretion of the study drug
• A positive urine drug screen or history of regular excessive alcohol consumption or use of tobacco-or nicotine-containing products in excess or from 24-hours prior to admission until discharge
• Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 halflives preceding the first dose of study med.
• Out of range blood pressure including current evidence of orthostatic change in blood pressure
• Abnormal ECG or history or current evidence of clinically important cardiac conduction abnormalities.
• Also excluded are: pregnant or breastfeeding female subjects; male subjects with partners currently pregnant; male and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as described in the protocol for the duration of the study and for at least 28 days after the last dose of investigational product.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Pfizer Clinical Research Unit

Brussels, , Belgium

Countries

Belgium

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A7331022&StudyName=A%20Study%20to%20Estimate%20the%20Effect%20of%20CYP3A4%20Inhibitors%20%28Itraconazole%2C%20Diltiazem%20or%20Verapamil%29%20on%20the%20Pharmacokinetics%20of%20Single%20Dose%20

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Other Identifiers

2014-001979-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

A7331022

Identifier Type: -

Identifier Source: org_study_id