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A Study to Determine the Effects of PF-04965842 on the Pharmacokinetics of Oral Contraceptive Steroids in Healthy Female Subjects

Last updated on March 19, 2019

Study Location
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, 06511 United States
Eligibility criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Females
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 female subjects of both childbearing and non-childbearing potential 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 blood pressure (BP) and pulse rate
measurement, 12 lead ECG, or clinical laboratory tests.

Female subjects of non-childbearing potential must meet at least 1 of the following

1. Achieved postmenopausal status, defined as follows: cessation of regular menses for at
least 12 consecutive months with no alternative pathological or physiological cause; 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.

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

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

- 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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- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological,
gynecologic or allergic disease (including drug allergies, but excluding untreated,
asymptomatic, seasonal allergies at the time of dosing).

- Evidence of acute exacerbation of dermatological condition (eg, AD or psoriasis) or
visible rash present during physical examination.

- Subjects, who according to the product label for OC, would be at increased risk if
dosed with OC.

Based on PORTIA product label, combination OCs should not be used in women with any of the
following conditions:

1. Thrombophlebitis or thromboembolic disorders.

2. A past history of deep-vein thrombophlebitis or thromboembolic disorders.

3. Cerebral-vascular or coronary artery disease.

4. Thrombogenic valvulopathies.

5. Thrombogenic rhythm disorders.

6. Diabetes mellitus with vascular involvement.

7. Uncontrolled hypertension.

8. Known or suspected carcinoma of the breast.

9. Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia.

10. Undiagnosed abnormal genital bleeding.

11. Cholestatic jaundice of pregnancy or jaundice with prior pill use.

12. Hepatic adenomas or carcinomas, or active liver disease, as long as liver function has
not returned to normal.

13. Known or suspected pregnancy.

14. Hypersensitivity to any of the components of Portia (LN and EE tablets).

15. Are receiving Hepatitis C drug combinations containing
ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for
alanine aminotransferase (ALT) elevations.

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

- A positive urine drug test.

- History of regular alcohol consumption exceeding 7 drinks/week for female
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.

- 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).

- Screening supine systolic BP of supine rest or Screening supine diastolic BP at least 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.

- Screening supine 12 lead ECG demonstrating a corrected QT (QTc) interval >450 msec or
a QRS interval >120 msec. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG
should be repeated 2 more times and the average of the 3 QTc or QRS values should be
used to determine the subject's eligibility.

- 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) or ALT level >= 1.5 × upper limit of normal

- Total bilirubin (TBili) level > 1 × ULN;

- Use of CYP2C19 inhibitors (eg, fluconazole, fluoxetine, fluvoxamine, ticlopidine
omeprazole, voriconazole, cimetidine, esomeprazole, and felbamate) or inducers (eg,
rifampin, ritonavir, efavirenz, enzalutamide, phenytoin, and St. John's Wort) within
28 days or 5 half-lives (whichever is longer) prior to dosing.

- Use of CYP2C9 inhibitors (eg, amiodarone, felbamate, fluconazole, miconazole,
piperine, diosmin, disulfiram, fluvastatin, fluvoxamine, voriconazole, efavirenz,
isoniazid) or inducers (eg, aprepitant, carbamazepine, enzalutamide, rifampin,
ritonavir, nevirapine, phenobarbital, and St. John's Wort) within 28 days or 5
half-lives (whichever is longer) prior to dosing.

- Use of CYP3A4 inhibitors (eg, ketoconazole, ciprofloxacin, diltiazem) or other
inducers (eg, phenytoin, carbamazepine) within 28 days or 5 half-lives (whichever is
longer) prior to dosing.

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

- History of active or latent or inadequately treated tuberculosis (TB) infection, or a
positive QuantiFERON-TB Gold test.

- Any history of chronic infections, any history of recurrent infections, any history of
latent infections, or any acute infection within 2 weeks of Screening.

- History of disseminated herpes zoster, or disseminated herpes simplex, or
recurrent localized dermatomal herpes zoster.

- History of systemic infection requiring hospitalization, parenteral antimicrobial
therapy, or considered clinically significant by the investigator within 6 months
prior to Screening.

- History of receiving a live vaccine within 6 weeks prior to the first dose of
investigational product, or is expected to receive a live vaccine within 6 weeks after
the last dose of investigational product.

- Have a known immunodeficiency disorder or a first-degree relative with a hereditary

- History or evidence of any malignancies with the exception of adequately treated or
excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical
carcinoma in situ.

- 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 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 hormonal methods of contraception (including oral and transdermal
contraceptives, injectable progesterone, progestin subdermal implants, progesterone
releasing intrauterine devices [IUDs], vaginal ring, and postcoital contraceptive methods)
and hormone replacement therapy must have been discontinued at least 28 days prior to the
first dose of investigational product.

Use of hormone based intravaginal creams (i.e., Estrace) for treatment of vaginal dryness,
itching, or burning due to menopause and/or vulvovaginal atrophy Depo Provera must have
been discontinued at least 6 months prior to the first dose of investigational product.

- Use of tobacco- or nicotine-containing products within 3 months of Screening or a
positive urine cotinine at Screening.

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

- History of sensitivity to heparin or heparin-induced thrombocytopenia.

- 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).

A positive hepatitis B surface antibody (HepBsAb) finding as a result of subject
vaccination is permissible.

- A current or past medical history of conditions associated with thrombocytopenia,
coagulopathy, or platelet dysfunction.

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

- Unwillingness to use an additional form of contraception for the duration of the study
and for the specified time after follow-up.

- History of discontinued use of OCs for medical reasons.

- Pregnant female subjects; breastfeeding female subjects; females of childbearing
potential who do not agree to use an acceptable method of nonhormonal contraception.

- 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.

- 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

A Study to Determine the Effects of PF-04965842 on the Pharmacokinetics of Oral Contraceptive Steroids in Healthy Female Subjects


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