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

Completed · Phase 1

Conditions studied: Healthy Subjects

In brief

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

Key facts

Study ID

NCT03762928

Run by

Pfizer

People needed

12

Starts

2018-12-07

Expected to finish

2019-02-21

Last updated by the study team

2019-03-26

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Pfizer New Haven Clinical Research Unit — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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