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Completed

NCT Number: NCT04594252

Copper Balance in Healthy Participants Administered ALXN1840

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.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Study Site

London, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

ALXN1840

Drug

Administered orally as tablets.

Other names: formerly WTX101

Primary outcomes

  1. Change From Baseline in Mean Daily Copper Balance Over 2 Weeks of Repeated Daily ALXN1840 Dosing (Over Days 4 to 15)

    Time frame: Baseline, Days 4 to 15

    Copper balance was defined as the difference in copper input and copper output. A negative copper balance indicated greater copper output than copper intake. Copper input was defined as the sum of all copper input as measured in all food and fluids over the specified period. Copper output was defined as the sum of all copper output as measured in urine and feces over the specified collection period. Baseline was defined as the average of the nonmissing values on or before first study drug administration from Day -4 to Day -1.

Secondary outcomes

  1. Mean Daily Copper Balance Over Two Weeks of Repeated ALXN1840 Dosing

    Time frame: Day 4 through Day 15

    Copper balance was defined by the difference in copper input and copper output. A negative copper balance indicated greater copper output than copper intake. Copper input was defined as the sum of all copper input as measured in all food and fluids over the specified period. Copper output was defined as the sum of all copper output as measured in urine and feces over the specified collection period.

  2. Change From Baseline in Mean Daily Molybdenum Balance at Steady State (Over Days 12 to 15)

    Time frame: Baseline, Days 12 to 15

    Molybdenum mass balance was defined as the difference in molybdenum input and molybdenum output. A negative molybdenum balance indicated greater molybdenum output than molybdenum intake. Molybdenum input was defined as the sum of all molybdenum input as measured in all food and fluids over the specified period. Molybdenum output was defined as the sum of all molybdenum output as measured in urine and feces over the specified collection period. Baseline was defined as the average of the nonmissing values on or before first study drug administration from Day -4 to Day -1.

  3. Change From Baseline in Total Molybdenum Excretion in Urine and Feces Averaged Over 2 Weeks of Dosing (Days 4 to 15)

    Time frame: Baseline, Days 4 to 15

    Molybdenum mass balance was defined as the difference in molybdenum input and molybdenum output. A negative molybdenum balance indicated greater molybdenum output than molybdenum intake. Molybdenum input was defined as the sum of all molybdenum input as measured in all food and fluids over the specified period. Molybdenum output was defined as the sum of all molybdenum output as measured in urine and feces over the specified collection period. Baseline was defined as the average of the nonmissing values on or before first study drug administration from Day -4 to Day -1. Molybdenum excretion for the Day 4 through Day 15 period included data averaged from Day 4 through Day 15.

  4. Mean Daily Molybdenum Balance Throughout the ALXN1840 Treatment Period (Day 1 Through Day 15)

    Time frame: Day 1 through Day 15

    Molybdenum mass balance was defined as the difference in molybdenum input and molybdenum output. A negative molybdenum balance indicated greater molybdenum output than molybdenum intake. Molybdenum input was defined as the sum of all molybdenum input as measured in all food and fluids over the specified period. Molybdenum output was defined as the sum of all molybdenum output as measured in urine and feces over the specified collection period.

  5. Copper Quantified in Food, Drink, Feces, and Urine Averaged Over 2 Weeks of Dosing

    Time frame: Days 4 to 15

    Copper balance for the Day 4 through Day 15 period included data averaged from Day 4 through Day 15.

  6. Copper Quantified in Food, Drink, Feces, and Urine From Day 1 Through Day 30

    Time frame: Day 1 through Day 30

    Copper balance for the Day 1 through Day 30 period included data averaged from Day 1 through Day 30.

  7. Plasma Total Copper Concentration and Labile Bound Copper (LBC) Concentration

    Time frame: Day 15 (predose and 24 hours postdose)

  8. Molybdenum Quantified in ALXN1840 Doses Given and in Food, Drink, Feces, And Urine

    Time frame: Day 1 through Day 30

    Molybdenum balance for the Day 1 through Day 30 period included data averaged from Day 1 through Day 30.

  9. Maximum Observed Plasma Concentration (Cmax) of Total Molybdenum and Plasma Ultrafiltrate (PUF) Molybdenum

    Time frame: Predose (within 1 hour prior to dosing) through 24 hours postdose on Day 1 and Day 15

  10. Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval (AUCtau) of Total Molybdenum and PUF Molybdenum

    Time frame: Predose (within 1 hour prior to dosing) through 24 hours postdose on Day 1 and Day 15

  11. Observed Concentration at the End of the Dosing Interval (Ctau) of Total Molybdenum and PUF Molybdenum

    Time frame: Predose (within 1 hour prior to dosing) through 24 hours postdose on Day 1 and Day 15

Sponsors and collaborators

Lead sponsor

Alexion Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 20, 2020
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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