Copper Balance in Healthy Participants Administered ALXN1840
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ALXN1840 Participants will be administered repeat doses of ALXN1840 30 milligrams (mg) for 15 days. |
Drug: ALXN1840
Administered orally as tablets.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline In Mean Daily Copper Balance At Steady State [Baseline, up to Day 15]
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.
Secondary Outcome Measures
- Mean Daily Copper Balance [Day 1 through Day 15]
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.
- Mean Daily Molybdenum Balance At Steady State [up to Day 15]
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).
- Change From Baseline In Total Molybdenum Excretion In Urine And Feces At Day 15 [Baseline, Day 15]
- Mean Daily Molybdenum Balance [Day 1 through Day 15]
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.
- Copper Quantified In Food, Drink, Feces, And Urine, Including Plasma Total And Labile Bound Copper (LBC) [up to Day 15]
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.
- Copper Quantified In Food, Drink, Feces, And Urine [Day 1 through Day 30]
Copper will be assessed through measurement of copper intake (food and drink), and copper output (in feces and urine).
- Molybdenum Specified In ALXN1840 Doses Given And Quantified In Food, Drink, Feces, And Urine [Day 1 through Day 30]
Molybdenum will be assessed through measurement of molybdenum intake (in food, drink, and ALXN1840), and molybdenum output (in feces and urine).
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Have regular bowel movements (at least once per day).
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Adequate venous access in the left or right arm to allow collection of study-required blood samples.
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Willing and able to adhere to all dietary requirements of the study.
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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).
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Willing and able to follow protocol-specified contraception requirements.
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Capable of giving signed informed consent.
Exclusion Criteria:
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Significant medical history (current or past).
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History or presence of gastrointestinal conditions including chronic constipation and irritable bowel syndrome.
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Supine blood pressure ≤ 90/60 millimeters of mercury (mmHg) or > 140/90 mmHg.
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Lymphoma, leukemia, or any malignancy within 3 years.
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Breast cancer within the past 10 years.
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Alanine aminotransferase, aspartate aminotransferase, or total bilirubin > upper limit of normal at Screening.
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Serum copper or serum ceruloplasmin below lower limit of normal on laboratory reference range at Screening.
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History of anemia or hemoglobin < 130 gram (g)/Liter (L) for men and hemoglobin < 115 g/L for women at Screening.
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History of benign ethnic neutropenia or absolute neutrophil count < 1500/microliter (uL); lymphocyte count below 1000/uL.
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QTcF> 450 millisecond (ms) for men and QTcF> 480 ms for women.
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Current or chronic history of liver disease or known hepatic or biliary abnormalities (except for asymptomatic gallstones).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinical Study Site | London | United Kingdom |
Sponsors and Collaborators
- Alexion Pharmaceuticals
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ALXN1840-HV-108