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

• Status: Completed
• Trial end date: 2019-02-21
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer
• Treatments: Efavirenz; Midazolam

Criteria

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.