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

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

Official Title
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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

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: PF-06651600
* Drug: midazolam
* Drug: efavirenz


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: midazolam/efavirenz<br> | Drug: midazolam<br>* single administration of midazolam 2 mg oral solution<br>Drug: efavirenz<br>* single administration of efavirenz 50 mg capsule<br>|
| Experimental: PF-06651600/midazolam/efavirenz<br> | Drug: PF-06651600<br>* 200 milligram (mg) PF-06651600 once daily (QD) orally for 11 days<br>Drug: midazolam<br>* single administration of midazolam 2 mg oral solution<br>Drug: efavirenz<br>* single administration of efavirenz 50 mg capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| single dose Area under the curve at last quantifiable infinity time of midazolam |  | Hour 0, 0,5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose | 
| Single dose Area under the Curve from time 0 to 72 hours post-dose of efavirenz |  | hour 0, 0,5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of subjects with significant change from baseline in vital signs |  | hour 0 on study days 1, 4, 10 and 13 post-dose | 
| number of subjects with significant change from baseline in laboratory safety tests results |  | study days -1, 4, 13 post-dose | 
| number of subjects with treatment emergent adverse events (TEAE) |  | Baseline up to 35 days post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PK, Phase 1