Bioavailability Study of 2 Oral Formulations of ALXN1840

Study Identifier:
ALXN1840-HV-109
ClinicalTrials.gov Identifier:
NCT04610580
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
Date
Jan 2021 - Mar 2021
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 55 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • No clinically significant history or presence of electrocardiogram findings
  • Body weight ≥50 to ≤100 kilograms (kg) and body mass index 18 to \<32 kg/meter squared for all participants
  • Willing and able to follow protocol-specified contraception requirements
Exclusion Criteria
  • History or presence of clinical and/or laboratory disorders
  • Abnormal blood pressure, defined as supine blood pressure ≤90/60 millimeters of mercury (mmHg) or \>140/90 mmHg
  • Lymphoma, leukemia, or any malignancy within the past 5 years
  • Alanine aminotransferase, aspartate aminotransferase, or total bilirubin \> upper limit of normal
  • Serum copper or serum ceruloplasmin below lower limit of normal
  • Hemoglobin \<130 grams (g)/liter (L) for males and hemoglobin \<115 g/L for females
  • Significant allergies
  • Smoker
Sex
Female & Male
Age
18 - 55 Years

Study Details

Medical Condition
  • Other
Study Drug
  • Drug: ALXN1840
Date
Jan 2021 - Mar 2021
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 55 Years years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • No clinically significant history or presence of electrocardiogram findings
  • Body weight ≥50 to ≤100 kilograms (kg) and body mass index 18 to \<32 kg/meter squared for all participants
  • Willing and able to follow protocol-specified contraception requirements
Exclusion Criteria
  • History or presence of clinical and/or laboratory disorders
  • Abnormal blood pressure, defined as supine blood pressure ≤90/60 millimeters of mercury (mmHg) or \>140/90 mmHg
  • Lymphoma, leukemia, or any malignancy within the past 5 years
  • Alanine aminotransferase, aspartate aminotransferase, or total bilirubin \> upper limit of normal
  • Serum copper or serum ceruloplasmin below lower limit of normal
  • Hemoglobin \<130 grams (g)/liter (L) for males and hemoglobin \<115 g/L for females
  • Significant allergies
  • Smoker

Protocol Summary

The study will assess the relative bioavailability of 2 different formulations of ALXN1840 in healthy participants.

Trial Locations

Location
Status
Location
Nucleus Network Pty Ltd.
Melbourne, Victoria, Australia, 3004
Status
N/A