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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

Last updated on March 14, 2019

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Study Location
Pfizer Clinical Research Unit
Brussels, , B-1070 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteers
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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.

NCT02319148
Pfizer
Completed
A Study to Estimate the Effect of CYP3A4 Inhibitors (Itraconazole, Diltiazem or Verapamil) on the Pharmacokinetics of Single Dose PF- 00489791 in Healthy Volunteers

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[email protected]

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