Evaluation of Pharmacokinetic Drug Drug Interaction Between PF-05221304 And PF-06865571 In Healthy Adult Subjects

Study Overview
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Brief Summary
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Drug drug interaction study between PF-05221304 and PF-06865571

Detailed Description
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A Phase 1, Open Label, Two-cohort, Non-randomized Fixed Sequence Study To Evaluate The Pharmacokinetic Drug Drug Interaction Between Pf-05221304 And Pf-06865571 In Healthy Adult Subjects

Official Title
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A Phase 1, Open Label, Two-cohort, Non-randomized Fixed Sequence Study To Evaluate The Pharmacokinetic Drug Drug Interaction Between Pf-05221304 And Pf-06865571 In Healthy Adult Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: PF-06865571 administered Day 7-14
* Drug: PF-06865571 administered Day 1-14
* Drug: PF-05221304 administered Day 1-14
* Drug: PF-05221304 administered Day 7-14


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Healthy female subjects of nonchildbearing potential and/or male subjects. Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb). Exclusion Criteria Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease. Any condition possibly affecting drug absorption. A positive urine drug test. Screening supine BP 140 mm Hg (systolic) or 90 mm Hg (diastolic), following at least 5 minutes of supine rest. Screening supine 12 lead ECG demonstrating a corrected QT (QTc) interval >450 msec or a QRS interval >120 msec. -

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: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Effect of PF-05221304 on PF-06865571 PK<br> | Drug: PF-06865571 administered Day 7-14<br>* PF-06865571 administered Q12hr on Days 7-14<br>Drug: PF-05221304 administered Day 1-14<br>* PF-05221304 administered Q12hr on Days 1-14<br>|
| Experimental: Effect of PF-06865571 on PF-05221304 PK<br> | Drug: PF-06865571 administered Day 1-14<br>* PF-06865571 administered Q12hr on Day 7-14<br>Drug: PF-05221304 administered Day 7-14<br>* PF-05221304 administered Q12hr Days 7-14<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arm 1: PF-05221304 Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) | Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 12 hours. | Day 7, 0-12 hours and Day 14 0-12 hours | 
| Arm 1: PF-05221304 Maximum observed concentration from Time Zero to End if Dosing Interval (Cmax) | Maximum observed concentration from Time Zero to End if Dosing Interval (Cmax) | Day 7, 0-12 hours and Day 14 0-12 hours | 
| Arm 2: PF-06865571 Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) | Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 12 hours. | Day 7, 0-12 hours and Day 14 0-12 hours | 
| Arm 2: PF-06865571 Maximum observed concentration from Time Zero to End if Dosing Interval (Cmax) | Maximum observed concentration from Time Zero to End if Dosing Interval (Cmax) | Day 7, 0-12 hours and Day 14 0-12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Treatment-emergent AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Drug was assessed by the investigator (Yes/No). Subjects with multiple occurrences of an AE within a category were counted once within the category. | Screening up to 28 days after last dose of study medication |