Analyses of Primary Endpoint Sample Clauses

Analyses of Primary Endpoint. The primary objective of this study is to assess the change from baseline in average daily Cu balance after 2 weeks of ALXN1840 treatment at 30 mg/day in healthy participants. Secondarily, the study will also assess whether a net negative Cu balance is achieved following ALXN1840 treatment. The study will also assess Mo balance at ALXN1840 PK steady state. The primary analysis will be performed using the Full Analysis Set. Change from baseline in average daily Cu balance over Days 4 to 15 will be summarized using descriptive statistics based on data as observed. The 95% confidence limits for the mean change from baseline will be provided. Copper balance is defined by the difference in Cu input and Cu output. A negative Cu balance will indicate greater Cu output than Cu intake. Copper input is defined as the sum of all Cu input as measured in all food and fluids over the specified period. Copper output will be defined as the sum of all Cu output as measured in urine and feces over the specified collection period. Daily balance values may also be calculated. The study assumes insensible Cu/Mo loss due in sweat does not change significantly with ALXN1840 treatment and is therefore not measured. While menstruation is not anticipated to significantly impact Cu/Mo balance, it may have minor impact on interpretation of the urine data. Dates of menstruation should be collected to help support data interpretation. Mo mass balance is defined as the difference in Mo input and Mo output. It will be calculated in an analogous manner as Cu balance and includes the additional Mo intake from ALXN1840. Mo mass balance will be calculated at steady state (Day 12 through Day 15) and over the entire treatment period (Day 1 through Day 30). The average daily Cu and Mo balance, and/or change from baseline in average daily Cu and Mo balance will be calculated using data from the following periods: • Day -4 through Day -1 representing the pre-dose baseline period (Cu/Mo balance) • Days 4 through Day 15 representing the 30 mg/day treatment period (Cu balance for primary and secondary endpoints) • Day 1 through Day 15 ALXN1840 treatment period (Mo mass balance and Cu as exploratory analyses) • Days 12 through Day 15 representing steady state treatment period (steady state Mo/Cu balance) • Days 1 through Day 30 representing the entire treatment and post-treatment period (total Mo and Cu balance) As ALXN1840 is expected to increase Cu removal through fecal excretion, Cu in stool will ...
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