A Study of PF-06651600 Effect on Rosuvastatin Pharmacokinetics in Healthy Participants

Study Overview
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Brief Summary
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A phase 1, 2-period, fixed-sequence, multiple-dose, open-label study of the effect of PF-06651600 on Rosuvastatin pharmacokinetics in healthy participants. Approximately 12 healthy male and/or female participants will be enrolled in the study.

Official Title
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A PHASE 1, 2-PERIOD FIXED SEQUENCE, MULTIPLE-DOSE, OPEN-LABEL STUDY TO ESTIMATE THE EFFECT OF PF-06651600 ON ROSUVASTATIN PHARMACOKINETICS IN HEALTHY PARTICIPANTS

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: PF-06651600
* Drug: Rosuvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and/or female participants who are healthy as determined by medical evaluation including medical history, full physical examination which includes blood pressure (BP) and pulse rate measurement, clinical laboratory tests, and 12-lead ECG. Body mass index (BMI) of 17.5 to 30.5 kg/m sq, and a total body weight greater than 50 kg (110 lb.). Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, dermatological or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). Participants with any of the following acute or chronic infections or infection history: Any infection requiring treatment within 2 weeks prior to the dosing visit. Any infection requiring hospitalization, parenteral antimicrobial therapy within 60 days of the first dose of rosuvastatin. Any infection judged to be an opportunistic infection or clinically significant by the investigator, within the past 6 months of the first dose of rosuvastatin. Known active or history of recurrent bacterial, viral, fungal, mycobacterial or other infections. History of recurrent (more than one episode of) localized dermatomal herpes zoster, or history of disseminated (single episode) herpes simplex or disseminated herpes zoster. Known presence 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.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-06651600 and Rosuvastatin<br>Period 1 is 4 days in length. On Day 1 of Period 1 participants will receive a single dose of Rosuvastatin 10 mg given as a tablet orally. Period 2 is 11 days in length and will immediately follow Period 1 with no washout. In Period 2, participants will be dosed with oral 200 mg PF-06651600 once-daily (QD) for 7 days. On Day 8 of Period 2, a single dose of 10 mg Rosuvastatin oral tablet will be administered following administration of the 200-mg dose of PF-06651600. Dosing with oral 200 mg PF-06651600 QD will continue until Day 10 of Period 2. | Drug: PF-06651600<br>* PF-06651600: 200 mg dose provided as four 50 mg oral tablets<br>Drug: Rosuvastatin<br>* 10 mg oral tablet<br>* Other names: Crestor ®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for rosuvastatin | AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf). | Period 1 (4 days) day 1 and period 2 (11 days) day 8 , 0 (pre-dose), 0.5, 1,2,3,4,5,6,8,10,12,16,24,36,48,and 72 hours post-dose | 
| Renal clearance (CLr) for rosuvastatin | CLr = total amount of drug collected in urine (Ae) divided by area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast). | Period 1 (4 days) day 1 and period 2 (11 days) day 8 , hours: [0-6], [6-12], [12-24], [24-48], and [48-72] post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetics (PK)