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NCT04179474 Study ID: 3110‐108‐002 Title: A

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NCT04179474 Study ID: 3110‐108‐002 Title: A NCT04179474 Study ID: 3110‐108‐002 Title: A Phase 1b, Two‐Part, Open‐Label, Fixed‐Sequence, Safety, Tolerability and Drug‐Drug Interaction Study Between Single Dose Erenumab or Galcanezumab and Multiple Dose Ubrogepant in Participants with Migraine Protocol Date: 14Aug2019 CONFIDENTIAL Protocol 3110-108-002 Ubrogepant (AGN-241688) Title Page Protocol Title: A Phase 1b, Two-Part, Open-Label, Fixed-Sequence, Safety, Tolerability and Drug-Drug Interaction Study Between Single Dose Erenumab or Galcanezumab and Multiple Dose Ubrogepant in Participants with Migraine Protocol Number: 3110-108-002 Product: Ubrogepant (AGN-241688, MK-1602) Brief Protocol Title: Drug-Drug Interaction Study of Ubrogepant with Erenumab or Galcanezumab Study Phase: 1b Sponsor Name and Legal Registered Address: Allergan Pharmaceuticals International Limited, Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland US Agent: Allergan Sales, LLC, 2525 Dupont Dr, Irvine, California 92612, USA Regulatory Agency Identifying Number(s): IND #113924 SAE Reporting Fax Number/Email: Business Unit Email Phone Fax Allergan Approval Date: 14 August 2019 1 GRD-CLN-T-01-01 v3.0 CONFIDENTIAL Protocol 3110-108-002 Ubrogepant (AGN-241688) Sponsor Signatories: Date Date The signatures of the sponsor signatories are collected on the protocol approval page. 2 GRD-CLN-T-01-01 v3.0 CONFIDENTIAL Protocol 3110-108-002 Ubrogepant (AGN-241688) Table of Contents Title Page .........................................................................................................................................1 Table of Contents.............................................................................................................................3 List of Tables ...................................................................................................................................7 1. Protocol Summary ..................................................................................................................8 1.1. Synopsis ......................................................................................................................8 2. Introduction...........................................................................................................................14 2.1. Study Rationale.........................................................................................................14 2.2. Background...............................................................................................................15 2.3. Benefit/Risk Assessment ..........................................................................................17 3. Objectives and Endpoints .....................................................................................................18 4. Study Design.........................................................................................................................19 4.1. Overall Design ..........................................................................................................19 4.2. Scientific Rationale for Study Design.......................................................................20 4.3. Justification for Dose ................................................................................................20 4.4. End of Study Definition ............................................................................................20 5. Study Population...................................................................................................................21 5.1. Inclusion Criteria ......................................................................................................21 5.2. Exclusion Criteria .....................................................................................................23 5.3. Lifestyle Considerations ...........................................................................................27 5.3.1. Meals and Dietary Restrictions..................................................................27 5.3.2. Caffeine, Alcohol, and Tobacco ................................................................27 5.3.3. Activity ......................................................................................................28 5.4. Screen Failures..........................................................................................................28 6. Study Intervention.................................................................................................................29 6.1. Study Intervention(s) Administered..........................................................................29 6.2. Preparation/Handling/Storage/Accountability..........................................................31 6.3. Measures to Minimize Bias: Randomization and Blinding ......................................31 6.4. Study Intervention Compliance ................................................................................31 6.5. Concomitant Therapy................................................................................................32 6.5.1. Prohibited Interventions and Washout Before the Study ..........................................................................................................32 6.5.2. Permitted Interventions..............................................................................33 6.5.3. Rescue Medicine........................................................................................34 6.5.4. Prohibited Interventions During the Study ................................................34 6.6. Dose Modification ....................................................................................................34 6.7. Intervention after the End of the Study.....................................................................34 3 GRD-CLN-T-01-01 v3.0 CONFIDENTIAL Protocol 3110-108-002 Ubrogepant (AGN-241688) 7. Discontinuation of Study Intervention and Participant Discontinuation/Withdrawal .................................................................................................35 7.1. Discontinuation of Study Intervention......................................................................35 7.2. Participant Discontinuation/Withdrawal from the Study..........................................36 7.3. Lost to Follow Up .....................................................................................................36 8. Study Assessments and Procedures ......................................................................................36 8.1. Efficacy Assessments................................................................................................37 8.2. Safety Assessments...................................................................................................37 8.2.1. Physical Examinations...............................................................................37 8.2.2. Vital Signs..................................................................................................37 8.2.3. Electrocardiograms ....................................................................................38 8.2.4. Clinical Safety Laboratory Assessments ...................................................38 8.2.5. Suicidal Risk Monitoring...........................................................................39 8.3. Adverse Events and Serious Adverse Events ...........................................................39 8.3.1. Time Period and Frequency for Collecting AE and SAE Information........................................................................................40 8.3.2. Method of Detecting AEs and SAEs .........................................................40 8.3.3. Follow-up of AEs and SAEs......................................................................40 8.3.4. Regulatory Reporting Requirements for SAEs..........................................41 8.3.5. Pregnancy...................................................................................................41 8.3.6. AEs of Special Interest...............................................................................41 8.3.6.1. Potential Hy’s Law Cases ...........................................................41 8.3.6.2. ALT or AST Elevations ..............................................................42 8.3.7. Medication Errors ......................................................................................43 8.4. Treatment of Overdose .............................................................................................43 8.5. Pharmacokinetics ......................................................................................................44 8.5.1. Blood PK Sampling Procedure ..................................................................44 8.5.3. Plasma PK and Bioanalysis ..................................................46 8.6. Pharmacodynamics ...................................................................................................46 8.7. Genetics.....................................................................................................................46 8.8. Biomarkers and Other Assessments..........................................................................46 8.9. Health Economics/Medical Resource Utilization and Health Economics.................................................................................................................47 9. Statistical Considerations......................................................................................................48
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