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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: PF-06651600; Drug: efavirenz; Drug: midazolam

Study type: Interventional

Funder types: Industry

Identifiers

NCT03762928

B7981017

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

midazolam/efavirenz

Experimental group

Treatment:

Drug: midazolam

Drug: efavirenz

PF-06651600/midazolam/efavirenz

Experimental group

Treatment:

Drug: midazolam

Drug: PF-06651600

Drug: efavirenz