Copper Balance in Healthy Participants Administered ALXN1840

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04594252
• Other study ID #: ALXN1840-HV-108
• Status: Completed
• Phase: Phase 1
• Start date: July 1, 2020
• Est. completion date: November 17, 2020

Study information

• Verified date: February 2021
• Source: Alexion Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: November 17, 2020
• Est. primary completion date: November 17, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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).

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• ALXN1840
Administered orally as tablets.

Locations

Country	Name	City	State
United Kingdom	Clinical Study Site	London

Sponsors (1)

Lead Sponsor	Collaborator
Alexion Pharmaceuticals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Change From Baseline In Total Molybdenum Excretion In Urine And Feces At Day 15		Baseline, Day 15
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Pharmacokinetics (PK): Maximum Concentration (Cmax) Of Plasma Total Molybdenum		predose through 24 hours postdose on Day 1 and Day 15
Secondary	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
Secondary	PK: Trough (Predose) Concentration Observed At The Start Of The Dosing Interval (Ctrough)		predose from Day 2 to Day 16