Status:
COMPLETED
ESTIMATION OF THE EFFECT OF MULTIPLE DOSE PF-06651600 ON THE PHARMACOKINETICS OF SINGLE DOSE MIDAZOLAM AND EFAVIRENZ
Lead Sponsor:
Pfizer
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The current study will estimate any inhibitive or inductive effect of PF-06651600 on the pharmacokinetics of midazolam and efavirenz.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2019
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03762928
Start Date
December 7 2018
End Date
February 21 2019
Last Update
March 26 2019
Active Locations (1)
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1
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, United States, 06511