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 |
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.
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.
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