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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteers

Intervention: itraconazole (Drug); diltiazem (Drug); SR verapamil (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer


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.

Clinical Details

Official title: A Phase 1, Randomized, Open-label, 3-sequence, 4-treatment, Incomplete Block Design To Estimate The Effect Of Steady State Cyp3a4 Inhibitors (Itraconazole, Diltiazem Or Verapamil) On The Pharmacokinetics Of Singe Dose Pf-00489791 In Healthy Volunteers

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome:

Maximum Observed Plasma Concentration (Cmax)

Area under the Concentration-Time Curve (AUC)

Secondary outcome:

Time to Reach Maximum Observed Plasma Concentration (Tmax)

Plasma Decay Half-Life (t1/2)

Apparent Oral Clearance (CL/F)

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

Apparent Volume of Distribution (Vz/F)


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.


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


- 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.

Locations and Contacts

Pfizer Clinical Research Unit, Brussels B-1070, Belgium
Additional Information

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

Starting date: July 2014
Last updated: December 12, 2014

Page last updated: August 23, 2015

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