A Study of the Cardiac Effects of ALXN1840 in Healthy Adults

Study Identifier:
ALXN1840-HV-107
ClinicalTrials.gov Identifier:
NCT04560816
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete

Available Documents

ProtocolStatistical Analysis Plan

Study Details

Medical Condition
  • Other
Study Drug
  • Drug: ALXN1840
  • Drug: Placebo
  • Drug: Moxifloxacin
Date
Jul 2020 - Mar 2021
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 50 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Nonsmoker.
  • Body weight at least 60 kilograms (kg) for males or 52 kg for females and body mass index ≥18.0 and ≤30.0 kg/meter squared.
  • Willing and able to follow protocol-specified contraception requirements.
  • Participant has no clinically significant history or presence of ECG findings.
Exclusion Criteria
  • History or presence of clinical and/or lab disorders.
  • Lymphoma, leukemia, or any malignancy within the past 5 years, or breast cancer within the past 10 years.
  • Participant has abnormal blood pressure, defined as a supine blood pressure \<90/50 millimeters of mercury (mm Hg) or \>140/90 mm Hg.
  • Serum potassium, calcium, or magnesium levels outside the normal range.
  • Serum copper and/or ceruloplasmin values below the lower limit of normal at Screening.
  • Female participant has hemoglobin \<10.8 grams/deciliter (g/dL) and male participant has hemoglobin \<12.5 g/dL.
  • Clinically significant multiple or severe allergies.
  • Alanine aminotransferase, aspartate aminotransferase, serum creatinine, or total bilirubin greater than upper limit of normal (with the exception of Gilbert's syndrome).
Sex
Female & Male
Age
18 - 50 Years

Study Details

Medical Condition
  • Other
Study Drug
  • Drug: ALXN1840
  • Drug: Placebo
  • Drug: Moxifloxacin
Date
Jul 2020 - Mar 2021
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 50 Years years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Nonsmoker.
  • Body weight at least 60 kilograms (kg) for males or 52 kg for females and body mass index ≥18.0 and ≤30.0 kg/meter squared.
  • Willing and able to follow protocol-specified contraception requirements.
  • Participant has no clinically significant history or presence of ECG findings.
Exclusion Criteria
  • History or presence of clinical and/or lab disorders.
  • Lymphoma, leukemia, or any malignancy within the past 5 years, or breast cancer within the past 10 years.
  • Participant has abnormal blood pressure, defined as a supine blood pressure \<90/50 millimeters of mercury (mm Hg) or \>140/90 mm Hg.
  • Serum potassium, calcium, or magnesium levels outside the normal range.
  • Serum copper and/or ceruloplasmin values below the lower limit of normal at Screening.
  • Female participant has hemoglobin \<10.8 grams/deciliter (g/dL) and male participant has hemoglobin \<12.5 g/dL.
  • Clinically significant multiple or severe allergies.
  • Alanine aminotransferase, aspartate aminotransferase, serum creatinine, or total bilirubin greater than upper limit of normal (with the exception of Gilbert's syndrome).

Protocol Summary

This study will evaluate the effect of a supratherapeutic dose of ALXN1840 on the heart rate (HR)-corrected QT interval (QTc) in healthy adult participants. Moxifloxacin will be used as the active control.

Trial Locations

Location
Status
Location
PPD Development, LP
Austin, Texas, United States, 78744
Status
N/A