ESTIMATION OF THE EFFECT OF MULTIPLE DOSE PF-06651600 ON THE PHARMACOKINETICS OF SINGLE DOSE MIDAZOLAM AND EFAVIRENZ



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:3/28/2019
Start Date:December 7, 2018
End Date:February 21, 2019

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A PHASE 1, RANDOMIZED, OPEN LABEL, 2-WAY CROSSOVER STUDY TO ESTIMATE THE EFFECT OF MULTIPLE DOSE PF-06651600 ON THE PHARMACOKINETICS OF SINGLE DOSE MIDAZOLAM AND EFAVIRENZ IN HEALTHY PARTICIPANTS

The current study will estimate any inhibitive or inductive effect of PF-06651600 on the
pharmacokinetics of midazolam and efavirenz.


Inclusion Criteria:

Male and female participants who are healthy Body mass index (BMI) of 17.5 to 30.5 kg/m2;
and a total body weight >50 kg

Exclusion Criteria:

- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological,
dermatological, or allergic disease

- Any condition possibly affecting drug absorption

- Known immunodeficiency.

- Infection with hepatitis B or hepatitis C viruses

- acute or chronic infections or infection history judged to be clinically significant
by the investigator

- History of any lymphoproliferative disorder

- known present or a history of malignancy other than a successfully treated or excised
non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in
situ.

- live (attenuated) vaccines within 6 weeks prior to the first dose of investigational
product.
We found this trial at
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New Haven, Connecticut 06511
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New Haven, CT
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