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