Phase 1
N=17
Copper Balance in Healthy Participants Administered ALXN1840
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT04594252 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Change From Baseline in Mean Daily Copper Balance Over 2 Weeks of Repeated Daily ALXN1840 Dosing (Over Days 4 to 15) — -0.0749; 0.6901; 0.4201 mg/day
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- ALXN1840 (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alexion Pharmaceuticals, Inc.
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Daily Copper Balance Over 2 Weeks of Repeated Daily ALXN1840 Dosing (Over Days 4 to 15) |
-0.0749; 0.6901; 0.4201 | — |
| SECONDARY Mean Daily Copper Balance Over Two Weeks of Repeated ALXN1840 Dosing |
0.7789; 1.0218; 0.9361 | — |
| SECONDARY Change From Baseline in Mean Daily Molybdenum Balance at Steady State (Over Days 12 to 15) |
1.7750; 0.6189; 1.0269 | — |
| SECONDARY Change From Baseline in Total Molybdenum Excretion in Urine and Feces Averaged Over 2 Weeks of Dosing (Days 4 to 15) |
2.6210; 2.5957; 2.6046; 2.0247; 1.9586; 1.9819 | — |
| SECONDARY Mean Daily Molybdenum Balance Throughout the ALXN1840 Treatment Period (Day 1 Through Day 15) |
2.5560; 2.2861; 2.3813 | — |
| SECONDARY Copper Quantified in Food, Drink, Feces, and Urine Averaged Over 2 Weeks of Dosing |
1.5039; 1.7178; 1.6423; 0.0270; 0.0108; 0.0165 | — |
| SECONDARY Copper Quantified in Food, Drink, Feces, and Urine From Day 1 Through Day 30 |
1.6117; 1.6673; 1.6476; 0.0252; 0.0124; 0.0169 | — |
| SECONDARY Plasma Total Copper Concentration and Labile Bound Copper (LBC) Concentration |
12.58931; 13.87256; 13.41964; 12.56570; 14.49816; 13.77349 | — |
| SECONDARY Molybdenum Quantified in ALXN1840 Doses Given and in Food, Drink, Feces, And Urine |
0.2618; 0.1414; 0.1839; 0.0014; 0.0017; 0.0016 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Total Molybdenum and Plasma Ultrafiltrate (PUF) Molybdenum |
303.000; 291.727; 295.706; 358.500; 382.333; 372.800 | — |
| SECONDARY Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval (AUCtau) of Total Molybdenum and PUF Molybdenum |
4860.289; 4439.012; 4587.698; 6770.905; 7496.724; 7206.397 | — |
| SECONDARY Observed Concentration at the End of the Dosing Interval (Ctau) of Total Molybdenum and PUF Molybdenum |
143.800; 140.436; 141.624; 218.833; 242.625; 232.429 | — |
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.
Eligibility Criteria
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 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).
Data sourced from ClinicalTrials.gov (NCT04594252). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.