Copper Balance in Healthy Participants Administered ALXN1840

Study Overview
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Brief Summary
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The study will assess the change from baseline in mean daily copper balance in healthy participants with repeat-dose administrations of ALXN1840 over 2 weeks.

Detailed Description
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This study will also characterize the steady state absorption, distribution, metabolism, and excretion (mass balance) of total molybdenum, which is a surrogate measure of ALXN1840 disposition. Safety will be monitored throughout the study.

Official Title
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A Phase 1, Open-label Study to Assess Copper Balance in Healthy Participants Following Administration of ALXN1840

Conditions
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Healthy

Intervention / Treatment
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* Drug: ALXN1840


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have regular bowel movements (at least once per day). Adequate venous access in the left or right arm to allow collection of study-required blood samples. Willing and able to adhere to all dietary requirements of the study. Body weight between 50 to 70 kilograms (kg) (inclusive) for female participants, and 65 to 85 kg (inclusive) for male participants, and body mass index within the range 18 to 25 kg/meters squared (inclusive). Willing and able to follow protocol-specified contraception requirements. Capable of giving signed informed consent. Exclusion Criteria: Significant medical history (current or past). History or presence of gastrointestinal conditions including chronic constipation and irritable bowel syndrome. Supine blood pressure ≤ 90/60 millimeters of mercury (mmHg) or > 140/90 mmHg. Lymphoma, leukemia, or any malignancy within 3 years. Breast cancer within the past 10 years. Alanine aminotransferase, aspartate aminotransferase, or total bilirubin > upper limit of normal at Screening. Serum copper or serum ceruloplasmin below lower limit of normal on laboratory reference range at Screening. History of anemia or hemoglobin < 130 gram (g)/Liter (L) for men and hemoglobin < 115 g/L for women at Screening. History of benign ethnic neutropenia or absolute neutrophil count < 1500/microliter (uL); lymphocyte count below 1000/uL. QTcF> 450 millisecond (ms) for men and QTcF> 480 ms for women. Current or chronic history of liver disease or known hepatic or biliary abnormalities (except for asymptomatic gallstones).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALXN1840<br>Participants will be administered repeat doses of ALXN1840 30 milligrams (mg) for 15 days. | Drug: ALXN1840<br>* Administered orally as tablets.<br>* Other names: formerly WTX101;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline In Mean Daily Copper Balance At Steady State | Copper balance is defined as the difference between the measured copper input in food and drink, and the measured copper elimination in urine and feces, and will be calculated as the average daily copper balance over the pre-defined collection periods. | Baseline, up to Day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Daily Copper Balance | Copper balance is defined as the difference between the measured copper input in food and drink, and the measured copper elimination in urine and feces, and will be calculated as the average daily copper balance over the collection period. | Day 1 through Day 15 | 
| Mean Daily Molybdenum Balance At Steady State | Molybdenum balance at steady state will be assessed through measurement of molybdenum intake (in food, drink, and ALXN1840), and molybdenum output (in feces and urine) and will be calculated as the average daily molybdenum balance over the collection period. Steady state is defined as molybdenum(out) equal to molybdenum(in). | up to Day 15 | 
| Change From Baseline In Total Molybdenum Excretion In Urine And Feces At Day 15 |  | Baseline, Day 15 | 
| Mean Daily Molybdenum Balance | Molybdenum balance will be assessed through measurement of molybdenum intake (in food, drink, and ALXN1840), and molybdenum output (in feces and urine), and will be calculated as the average daily molybdenum balance over the collection period. | Day 1 through Day 15 | 
| Copper Quantified In Food, Drink, Feces, And Urine, Including Plasma Total And Labile Bound Copper (LBC) | Copper will be assessed through measurement of copper intake (food and drink), and copper output (in feces and urine), as well as plasma total and LBC. | up to Day 15 | 
| Copper Quantified In Food, Drink, Feces, And Urine | Copper will be assessed through measurement of copper intake (food and drink), and copper output (in feces and urine). | Day 1 through Day 30 | 
| Molybdenum Specified In ALXN1840 Doses Given And Quantified In Food, Drink, Feces, And Urine | Molybdenum will be assessed through measurement of molybdenum intake (in food, drink, and ALXN1840), and molybdenum output (in feces and urine). | Day 1 through Day 30 | 
| Pharmacokinetics (PK): Maximum Concentration (Cmax) Of Plasma Total Molybdenum |  | predose through 24 hours postdose on Day 1 and Day 15 | 
| PK: Area Under The Curve (AUC) From Time 0 To The Time Of Last Measurable Concentration (AUCt) Of Plasma Total Molybdenum |  | predose through 24 hours postdose on Day 1 and Day 15 | 
| PK: Trough (Predose) Concentration Observed At The Start Of The Dosing Interval (Ctrough) |  | predose from Day 2 to Day 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Copper Balance, Molybdenum Balance, Healthy, ALXN1840