Study of Oral ALXN1840 at 2 Dose Strengths in Healthy Adults

Study Identifier:
ALXN1840-HV-104
ClinicalTrials.gov Identifier:
NCT05303324
EudraCT Identifier:
2019-000516-28
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
Jul 2019 - Oct 2019
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 45 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Body weight ≤ 100 kilograms (kg) and body mass index within the range 18-25 kg/meter squared, inclusive, at Screening.
  • Negative serum pregnancy test at Screening and Day -1 for all women of childbearing potential.
  • Willing to adhere to contraception requirements.
  • Satisfactory medical assessment with no clinically significant or relevant abnormalities.
Exclusion Criteria
  • Current or recurrent/chronic disease
  • Positive test for hepatitis B surface antigen or human immunodeficiency virus antibody at Screening.
  • Acute or chronic hepatitis C virus infection.
  • History of hypersensitivity to ALXN1840 or its excipients or any significant allergic reaction.
  • Use of prescription medications (excluding oral contraceptives) within 14 days prior to dosing on Day 1, except with prior approval of the Sponsor.
  • Participation (that is, last protocol-required study visit) in a clinical study within 90 days before initiation of dosing on Day 1.
  • Serum ceruloplasmin value outside of the normal range at Screening
  • Female participants who were breastfeeding.
  • Prior exposure to ALXN1840.
  • Major surgery or hospitalization within 90 days prior to dosing on Day 1.
Sex
Female & Male
Age
18 - 45 Years

Study Details

Medical Condition
  • Other
Study Drug
  • Drug: ALXN1840
Date
Jul 2019 - Oct 2019
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 45 Years years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Body weight ≤ 100 kilograms (kg) and body mass index within the range 18-25 kg/meter squared, inclusive, at Screening.
  • Negative serum pregnancy test at Screening and Day -1 for all women of childbearing potential.
  • Willing to adhere to contraception requirements.
  • Satisfactory medical assessment with no clinically significant or relevant abnormalities.
Exclusion Criteria
  • Current or recurrent/chronic disease
  • Positive test for hepatitis B surface antigen or human immunodeficiency virus antibody at Screening.
  • Acute or chronic hepatitis C virus infection.
  • History of hypersensitivity to ALXN1840 or its excipients or any significant allergic reaction.
  • Use of prescription medications (excluding oral contraceptives) within 14 days prior to dosing on Day 1, except with prior approval of the Sponsor.
  • Participation (that is, last protocol-required study visit) in a clinical study within 90 days before initiation of dosing on Day 1.
  • Serum ceruloplasmin value outside of the normal range at Screening
  • Female participants who were breastfeeding.
  • Prior exposure to ALXN1840.
  • Major surgery or hospitalization within 90 days prior to dosing on Day 1.

Protocol Summary

To assess the relative bioavailability of ALXN1840 administered orally as a single enteric-coated (EC) tablet (reference, Treatment A) versus three EC tablets (test, Treatment B).

Trial Locations

Location
Status
Location
Clinical Trial Site
London, United Kingdom, SE11YR
Status
N/A