Copper Balance in Healthy Participants Administered ALXN1840

Alexion Pharmaceuticals, Inc.17 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

ALXN1840DRUG

Administered orally as tablets.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

Clinical Study Site

London, United Kingdom

Outcomes

Primary Outcomes

Change From Baseline in Mean Daily Copper Balance Over 2 Weeks of Repeated Daily ALXN1840 Dosing (Over 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.

Time frame: Baseline, Days 4 to 15

Secondary Outcomes

Mean Daily Copper Balance Over Two Weeks of Repeated ALXN1840 Dosing

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.

Time frame: Day 4 through Day 15

Change From Baseline in Mean Daily Molybdenum Balance at Steady State (Over 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.

Time frame: Baseline, Days 12 to 15

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

Data from ClinicalTrials.gov

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