Copper Balance in Healthy Participants Administered ALXN1840

NCT04594252 | Completed Phase 1 Results FDA Drug

• 1 other identifier: ALXN1840-HV-108
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Copper Balance; Molybdenum Balance; Healthy; ALXN1840

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Days 4 to 15

Secondary Outcomes (11)

• Mean Daily Copper Balance Over Two Weeks of Repeated ALXN1840 Dosing

  Day 4 through Day 15

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

  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)

  Baseline, Days 4 to 15

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

  Day 1 through Day 15

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

  Days 4 to 15

Study Arms (1)

ALXN1840

EXPERIMENTAL

Participants will be administered repeat doses of ALXN1840 30 milligrams (mg) for 15 days.

Drug: ALXN1840

Interventions

ALXN1840 DRUG

Administered orally as tablets.

Also known as: formerly WTX101

ALXN1840

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Alexion Pharmaceuticals, Inc.: lead

Study Sites (1)

Clinical Study Site

London, United Kingdom

Location

Results Point of Contact

• Title: Alexion Pharmaceuticals Inc.
• Organization: Alexion Pharmaceuticals Inc.

clinicaltrials@alexion.com

+1 855-752-2356

Study Officials

• Eugene S. Swenson, MD, PhD

  Alexion Pharmaceuticals, Inc.

  STUDY DIRECTOR

• Peter Ksenuk, MD

  Alexion Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 20, 2020
• Study Start: July 1, 2020
• Primary Completion: November 18, 2020
• Study Completion: November 18, 2020
• Last Updated: August 19, 2024
• Results First Posted: August 19, 2024

Record last verified: 2024-03

Locations

GB (1)