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A Phase 1, Randomized, 2-Way Crossover, Open Label PF-04965842 Protocol B7451034 Final Protocol, 01 November 2018 A PHASE 1, RANDOMIZED, 2-WAY CROSSOVER, OPEN LABEL STUDY TO ESTIMATE THE EFFECT OF PF-04965842 ON MATE1/2K ACTIVITY, USING METFORMIN AS A PROBE, IN HEALTHY PARTICIPANTS Investigational Product Number: PF-04965842 Investigational Product Name: Not Applicable (N/A) United States (US) Investigational New CCI Drug (IND) Number: European Clinical Trials Database 2018-003683-31 (EudraCT) Number: Protocol Number: B7451034 Phase: 1 Short Title: A Phase 1 Study of PF-04965842 Effect on MATE1/2K Activity in Healthy Participants 090177e1927d017a\Approved\Approved On: 20-Dec-2019 05:49 (GMT) Page 1 PF-04965842 Protocol B7451034 Final Protocol, 01 November 2018 Protocol Amendment Summary of Changes Table Document History Document Version Date Summary of Changes and Rationale Original protocol 1 November 2018 Not Applicable (N/A) 090177e1927d017a\Approved\Approved On: 20-Dec-2019 05:49 (GMT) Page 2 PF-04965842 Protocol B7451034 Final Protocol, 01 November 2018 TABLE OF CONTENTS LIST OF TABLES.....................................................................................................................7 1. PROTOCOL SUMMARY.....................................................................................................8 1.1. Synopsis ....................................................................................................................8 1.2. Schema ....................................................................................................................12 1.3. Schedule of Activities (SoA)...................................................................................13 2. INTRODUCTION ...............................................................................................................16 2.1. Study Rationale .......................................................................................................16 2.2. Background .............................................................................................................16 2.2.1. Mechanism of Action/Indication ................................................................16 2.2.2. Overview of Disease State..........................................................................17 2.2.3. Rationale for Development of PF-04965842..............................................18 2.2.4. Previous Human Experience with PF-04965842........................................18 2.2.4.1. Summary of Safety Data from Completed Studies ...................18 2.2.4.2. Summary of PF-04965842 Pharmacokinetics, Metabolism and In Vitro Enzymology ..................................................................19 2.3. Benefit/Risk Assessment.........................................................................................22 3. OBJECTIVES AND ENDPOINTS .....................................................................................22 4. STUDY DESIGN.................................................................................................................23 4.1. Overall Design.........................................................................................................23 4.2. Scientific Rationale for Study Design.....................................................................24 4.3. Justification for Dose ..............................................................................................25 4.4. End of Study Definition ..........................................................................................26 5. STUDY POPULATION ......................................................................................................26 5.1. Inclusion Criteria.....................................................................................................26 5.2. Exclusion Criteria....................................................................................................27 5.3. Lifestyle Considerations..........................................................................................30 5.3.1. Meals and Dietary Restrictions...................................................................30 5.3.2. Caffeine, Alcohol, and Tobacco .................................................................31 5.3.3. Activity .......................................................................................................31 5.3.4. Contraception..............................................................................................31 5.4. Screen Failures ........................................................................................................32 090177e1927d017a\Approved\Approved On: 20-Dec-2019 05:49 (GMT) Page 3 PF-04965842 Protocol B7451034 Final Protocol, 01 November 2018 6. STUDY INTERVENTION..................................................................................................32 6.1. Study Intervention(s) Administered ........................................................................32 6.1.1. Administration ............................................................................................32 6.2. Preparation/Handling/Storage/Accountability ........................................................33 6.2.1. Preparation and Dispensing ........................................................................34 6.3. Measures to Minimize Bias: Randomization and Blinding.....................................34 6.3.1. Allocation to Investigational Product .........................................................34 6.4. Study Intervention Compliance...............................................................................35 6.5. Concomitant Therapy..............................................................................................35 6.5.1. Rescue Medicine.........................................................................................35 6.6. Dose Modification...................................................................................................35 6.7. Intervention After the End of the Study..................................................................35 7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT DISCONTINUATION/WITHDRAWAL...........................................................................36 7.1. Discontinuation of Study Intervention ....................................................................36 7.2. Participant Discontinuation/Withdrawal From the Study .......................................36 7.3. Lost to Follow up ....................................................................................................37 8. STUDY ASSESSMENTS AND PROCEDURES...............................................................37 8.1. Efficacy Assessments..............................................................................................38 8.2. Safety Assessments .................................................................................................39 8.2.1. Physical Examinations................................................................................39 8.2.2. Vital Signs ..................................................................................................39 8.2.2.1. Temperature ..............................................................................39 8.2.3. Electrocardiograms.....................................................................................39 8.2.4. Clinical Safety Laboratory Assessments ....................................................41 8.2.5. Pregnancy Testing ......................................................................................41 8.3. Adverse Events and Serious Adverse Events..........................................................42 8.3.1. Time Period and Frequency for Collecting AE and SAE Information.......42 8.3.1.1. Reporting SAEs to Pfizer Safety...............................................42 8.3.1.2. Recording Nonserious AEs and SAEs on the CRF...................43 8.3.2. Method of Detecting AEs and SAEs ..........................................................43 8.3.3. Follow-up of AEs and SAEs.......................................................................43 090177e1927d017a\Approved\Approved On: 20-Dec-2019 05:49 (GMT) Page 4 PF-04965842 Protocol B7451034 Final Protocol, 01 November 2018 8.3.4. Regulatory Reporting Requirements for SAEs...........................................43 8.3.5. Exposure During Pregnancy or Breastfeeding, and Occupational Exposure ..........................................................................................................44 8.3.5.1. Exposure During Pregnancy......................................................44 8.3.5.2. Exposure During Breastfeeding ................................................44 8.3.5.3. Occupational Exposure .............................................................44 8.3.6. Medication Errors .......................................................................................44 8.4. Treatment of Overdose............................................................................................45 8.5. Pharmacokinetics ....................................................................................................46 8.5.1. Plasma for Metformin Analysis..................................................................46 8.5.2. Urine for Metformin Analysis ....................................................................46 8.6. Pharmacodynamics..................................................................................................47 8.7. Genetics...................................................................................................................47
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