Clinical trial NCT04594252: Copper Balance in Healthy Participants Administered ALXN1840
Official title: A Phase 1, Open-label Study to Assess Copper Balance in Healthy Participants Following Administration of ALXN1840
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Copper Balance
Molybdenum Balance
Healthy
ALXN1840
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2020-10-20
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Have regular bowel movements (at least once per day).
2. Adequate venous access in the left or right arm to allow collection of study-required blood samples.
3. Willing and able to adhere to all dietary requirements of the study.
4. 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).
5. Willing and able to follow protocol-specified contraception requirements.
6. Capable of giving signed informed consent.

Exclusion Criteria:

1. Significant medical history (current or past).
2. History or presence of gastrointestinal conditions including chronic constipation and irritable bowel syndrome.
3. Supine blood pressure ≤ 90/60 millimeters of mercury (mmHg) or \> 140/90 mmHg.
4. Lymphoma, leukemia, or any malignancy within 3 years.
5. Breast cancer within the past 10 years.
6. Alanine aminotransferase, aspartate aminotransferase, or total bilirubin \> upper limit of normal at Screening.
7. Serum copper or serum ceruloplasmin below lower limit of normal on laboratory reference range at Screening.
8. History of anemia or hemoglobin \< 130 gram (g)/Liter (L) for men and hemoglobin \< 115 g/L for women at Screening.
9. History of benign ethnic neutropenia or absolute neutrophil count \< 1500/microliter (uL), lymphocyte count below 1000/uL.
10. QTcF\> 450 millisecond (ms) for men and QTcF\> 480 ms for women.
11. Current or chronic history of liver disease or known hepatic or biliary abnormalities (except for asymptomatic gallstones).

Primary outcomes:
measure: Change From Baseline in Mean Daily Copper Balance Over 2 Weeks of Repeated Daily ALXN1840 Dosing (Over Days 4 to 15)
timeFrame: Baseline, Days 4 to 15
Secondary outcomes:
measure: Mean Daily Copper Balance Over Two Weeks of Repeated ALXN1840 Dosing
timeFrame: Day 4 through Day 15
measure: Change From Baseline in Mean Daily Molybdenum Balance at Steady State (Over Days 12 to 15)
timeFrame: Baseline, Days 12 to 15
measure: Change From Baseline in Total Molybdenum Excretion in Urine and Feces Averaged Over 2 Weeks of Dosing (Days 4 to 15)
timeFrame: Baseline, Days 4 to 15
measure: Mean Daily Molybdenum Balance Throughout the ALXN1840 Treatment Period (Day 1 Through Day 15)
timeFrame: Day 1 through Day 15
measure: Copper Quantified in Food, Drink, Feces, and Urine Averaged Over 2 Weeks of Dosing
timeFrame: Days 4 to 15
measure: Copper Quantified in Food, Drink, Feces, and Urine From Day 1 Through Day 30
timeFrame: Day 1 through Day 30
measure: Plasma Total Copper Concentration and Labile Bound Copper (LBC) Concentration
timeFrame: Day 15 (predose and 24 hours postdose)
measure: Molybdenum Quantified in ALXN1840 Doses Given and in Food, Drink, Feces, And Urine
timeFrame: Day 1 through Day 30
measure: Maximum Observed Plasma Concentration (Cmax) of Total Molybdenum and Plasma Ultrafiltrate (PUF) Molybdenum
timeFrame: Predose (within 1 hour prior to dosing) through 24 hours postdose on Day 1 and Day 15
measure: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval (AUCtau) of Total Molybdenum and PUF Molybdenum
timeFrame: Predose (within 1 hour prior to dosing) through 24 hours postdose on Day 1 and Day 15
measure: Observed Concentration at the End of the Dosing Interval (Ctau) of Total Molybdenum and PUF Molybdenum
timeFrame: Predose (within 1 hour prior to dosing) through 24 hours postdose on Day 1 and Day 15
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Clinical Study Site
Study officials:
affiliation: Alexion Pharmaceuticals, Inc.
name: Eugene S. Swenson, MD, PhD
role: STUDY_DIRECTOR
affiliation: Alexion Pharmaceuticals, Inc.
name: Peter Ksenuk, MD
role: STUDY_DIRECTOR
References: