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A Study To Determine The Effect Of Single-dose PF-04965842 On QTc Interval In Healthy Volunteers Compared With Placebo and Moxifloxacin

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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1. Healthy female subjects of nonchildbearing potential and/or male subjects who, at the
time of screening, are 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 BP and pulse rate measurement, 12-lead

ECG, or clinical laboratory tests. Female subjects of nonchildbearing potential must
meet at least 1 of the following criteria:

1. Achieved postmenopausal status, defined as follows: cessation of regular menses
for at least 12 consecutive months with no alternative pathological or
physiological cause; status may be confirmed with a serum follicle-stimulating
hormone (FSH) level confirming the postmenopausal state;

2. Have undergone a documented hysterectomy and/or bilateral oophorectomy;

3. Have medically confirmed ovarian failure. All other female subjects (including
female subjects with tubal ligations) are considered to be of childbearing
potential.

2. Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

3. Evidence of a personally signed and dated informed consent document indicating that
the subject has been informed of all pertinent aspects of the study.

4. Subjects who are willing and able to comply with all scheduled visits, treatment plan,
laboratory tests, and other study procedures.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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1. Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic (including alcoholic liver
disease, nonalcoholic steatohepatitis (NASH), autoimmune hepatitis, and hereditary
liver diseases), psychiatric, neurological, or allergic disease (including drug
allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of
dosing).

2. Evidence or history of clinically significant dermatological condition (eg, contact
dermatitis or psoriasis) or visible rash present during physical examination.

3. Subjects, who according to the product label for moxifloxacin, would be at increased
risk if dosed with moxifloxacin (ie, including but not limited to subjects with
history of myasthenia gravis, tendinitis/tendon rupture).

4. Self-reported history or risk factors for QT prolongation or torsades de pointes (eg,
organic heart disease, congestive heart failure, hypokalemia, hypomagnesaemia,
congenital long QT syndrome, myocardial ischemia or infarction), congenital deafness,
family history of sudden death, and family history of long QT syndrome.

5. Any condition possibly affecting drug absorption (eg, gastrectomy).

6. A positive urine drug test.

7. History of regular alcohol consumption exceeding 14 drinks/week for female subjects or
21 drinks/week for male subjects (1 drink = 5 ounces [150 mL] of wine or 12 ounces
[360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months before
screening.

8. Treatment with an investigational drug within 30 days (or as determined by the local
requirement) or 5 half-lives preceding the first dose of investigational product
(whichever is longer).

9. Subjects with known prior participation (ie, randomized and received at least 1 dose
of investigational product) in a trial involving PF-04965842.

10. Screening supine systolic BP supine rest OR Screening supine diastolic BP 5 minutes of supine rest. If a subject meets any of these criteria, the BP should be
repeated 2 more times and the average of the 3 BP values should be used to determine
the subject's eligibility.

11. Screening supine 12-lead ECG demonstrating: QTcF >450 msec OR QRS interval >120 msec.
If QTcF exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more
times and the average of the 3 QTcF or QRS values should be used to determine the
subject's eligibility.

12. Subjects with ANY of the following abnormalities in clinical laboratory tests at
screening, as assessed by the study-specific laboratory and confirmed by a single
repeat test, if deemed necessary:

Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transminase (SGOT) or
alanine aminotransferase (ALT)/serum glutamic pyruvic transminase (SGPT) limit of normal (ULN).

Total bilirubin level 1.5 × ULN; subjects with a history of Gilbert's syndrome may
have direct bilirubin measured and would be eligible for this study provided the
direct bilirubin level is ULN.

13. Known relevant history of elevated liver function tests (LFTs).

14. History of tuberculosis (TB) or active or latent or inadequately treated infection.

15. Fertile male subjects who are unwilling or unable to use a highly effective method of
contraception as outlined in this protocol for the duration of the study and for at
least 28 days after the last dose of investigational product.

16. Use of prescription or nonprescription drugs and dietary supplements within 7 days or
5 half-lives (whichever is longer) prior to the first dose of investigational product.
As an exception, acetaminophen/paracetamol may be used at doses of 1g/day. Limited use
of nonprescription medications that are not believed to affect subject safety or the
overall results of the study may be permitted on a case-by-case basis following
approval by the sponsor. Herbal supplements and hormone replacement therapy must have
been discontinued at least 28 days prior to the first dose of investigational product.

17. Use of tobacco- or nicotine- containing products in excess of the equivalent of 5
cigarettes per day.

18. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
within 60 days prior to dosing.

19. History of hypersensitivity, allergy, severe adverse drug reaction or intolerance to
quinolone antibiotics, including moxifloxacin.

20. History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive
testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody
(HepBcAb), or hepatitis C antibody (HCVAb). As an exception, a positive hepatitis B
surface antibody (HepBsAb) finding as a result of subject vaccination is permissible.

21. Unwilling or unable to comply with the criteria in the Lifestyle Requirements section
of this protocol.

22. Subjects who are investigator site staff members directly involved in the conduct of
the study and their family members, site staff members otherwise supervised by the
investigator, or subjects who are Pfizer employees, including their family members,
directly involved in the conduct of the study.

23. Other acute or chronic medical or psychiatric condition including recent (within the
past year) or active suicidal ideation or behavior or laboratory abnormality that may
increase the risk associated with study participation or investigational product
administration or may interfere with the interpretation of study results and, in the
judgment of the investigator, would make the subject inappropriate for entry into this
study.

NCT03386279
Pfizer
Completed
A Study To Determine The Effect Of Single-dose PF-04965842 On QTc Interval In Healthy Volunteers Compared With Placebo and Moxifloxacin

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