Schema Sample Clauses

Schema. A schema definition corresponding to the conceptual models is available at ▇▇▇▇://▇▇▇.▇▇▇.▇▇/cwas/SERES/2014/DRAFT/schema.
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Schema. The study design is presented in Figure 1. Admit to CRU Day -8 Baseline I/O Days -4 through -1 Treatment I/O Days 1 through 30 ALXN1840 30 mg/dayTreatment Period Days -35 to -9 Screening Day -7 Day -4 Enrollment Day -1 Day 1 Day 4 Day 7 Day 15 Day 16 Day 30 Day 43 Participants will be admitted to the CRU on Day -8 and discharged on Day 31. Participants eligible for the study will be enrolled (assigned a subject number) on Day -7. A Cu- and Mo-controlled diet will be initiated on Day -7 and will be continued through Day 30. Participants will be administered ALXN1840 at a dose of 30 mg/day on Day 1 through Day 15, with post-treatment period starting at Day 16. Total intake and total output (I/O) samples for measurement of Cu and Mo will be collected during the baseline (Day -4 through Day -1), treatment (Day 1 through Day 15), and post-treatment periods (Day 16 through Day 31). I/O defines the period in which all intake (food and drink) and all output (urine and feces) will be collected for the measurement of Cu and Mo. Intensive PK/PD sampling will occur on Day 1 and Day 15. Pre-dose PK/PD samples will be collected on Days 2 (Day 1, Hour 24), 3, 5, 8, 11, and 14. During the post-treatment period, PK/PD samples will be collected on Days 16, 18, 21, 24, 27, and 30. Abbreviations: CRU = clinical research unit; EOS = end of study; I/O = input/output.
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Related to Schema

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