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A Study to Determine the Effects of PF-04965842 on Midazolam PK in Healthy Volunteers

Last updated on March 14, 2019

Study Location
Pfizer Clinical Research Unit
Brussels, , B-1070 Belgium
Eligibility criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Phase 1
Females and Males
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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- Evidence of a personally signed and dated informed consent document indicating that
the subject has been informed of all pertinent aspects of the study

- Willing and able to comply with scheduled visits, treatment plan, laboratory tests and
other study procedures

- Healthy female subjects and/or male subjects who, at the time of screening, are
between the ages of 18 and 55 years, inclusive

- Female subjects with child-bearing potential must not be intending to become pregnant,
currently pregnant, or lactating. Conditions apply: negative pregnancy test, effective
method of contraception

- Non-childbearing potential must meet at least 1 of the following criteria: documented
hysterectomy and/or bilateral oophorectomy, ovarian failure, achieved postmenopausal
status confirmed with FSH

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

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, GI, CV, hepatic, psych, neurological, or allergic disease (including drug
allergies, but excluding seasonal)

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

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

- Self-reported history or risk factors for QT prolongation or torsades de pointes,
congenital deafness, family history of sudden death, and family history of long QT

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

- A positive urine drug test

- History of regular alcohol consumption exceeding 14 for female or 21 for male
drinks/week (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard
liquor) within 6 months of 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)

- Following at least 5 minutes of supine rest, screening supine systolic BP >=140 mm Hg, or screening supine diastolic BP =90 mm Hg. Any criteria
met, BP should be repeated

- 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

- AST/SGOT or ALT/SGPT >=1.5 × ULN. Total bilirubin level >1× ULN; subjects with a hx of
Gilbert's syndrome must have direct bilirubin elevated liver function tests (LFTs)

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

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

- History of sensitivity to heparin or heparin-induced thrombocytopenia

- Pregnant or breastfeeding female; fertile male and WOCBP unwilling to use a highly
effective method of contraception through study duration and for at least 28 days
after the last dose

- Use of medications and dietary supplements within 7 days or 5 half-lives prior to
first dose, acetaminophen/paracetamol hormonal methods of contraception

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

- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
within 60 days prior to first dose of investigational product

- History of hypersensitivity to midazolam or any other bezodiazapine

- History of HIV, hepatitis B or C; positive testing for HIV, HepBsAg, HepBcAb or HCVAb.
As an exception, a positive HepBsAb as a result of subject vaccination is permissible

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

- Investigator site staff members and their family members, site staff members otherwise
supervised by the investigator, or subjects who are Pfizer employees, including their
family members

- Other medical or psych condition including active suicidal ideation/ behavior or lab
abnormality that the investigator deems inappropriate for this study or may interfere
with study results

- Have any malignancies or have a history of 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

- Subjects at significant risk of suicidal or violent behavior

A Study to Determine the Effects of PF-04965842 on Midazolam PK in Healthy Volunteers


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