A Drug Interaction Study Between Danicopan and Midazolam, Fexofenadine, and Mycophenolate Mofetil in Healthy Participants

Study Identifier:
ACH471-010
ClinicalTrials.gov Identifier:
NCT03108274
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete

Study Details

Medical Condition
  • Other
Study Drug
  • Drug: Danicopan
  • Drug: Midazolam
  • Drug: Fexofenadine
  • Drug: Mycophenolate Mofetil
Date
Apr 2017 - Jun 2017
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 60 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Healthy was defined as having no clinically relevant abnormalities identified by a detailed medical history, physical examination, blood pressure and heart rate measurements, 12-lead electrocardiogram, and clinical laboratory tests.
  • Body mass index of 18.5 to 32 kilograms (kg)/square meter with a minimum body weight of 50 kg.
Exclusion Criteria
  • Mentally or legally incapacitated or significant emotional problems.
  • Any condition that might interfere with drug absorption.
  • History of sensitivity to study medication or other drug allergies.
  • Body temperature greater than or equal to 38°Celsius on Day -1 or Day 1 predose; history of febrile illness within 14 days of the first dose.
  • Positive urine drug test; current tobacco/nicotine users and smokers; consumption of alcohol within 72 hours of study drug administration.
  • Participated in another clinical study within 28 days prior to the first dose.
  • Significant laboratory abnormalities.
  • Blood donation of more than 500 milliliters within 3 months of the first dose; received a blood transfusion or blood products within 6 months to the first dose.
Sex
Female & Male
Age
18 - 60 Years

Study Details

Medical Condition
  • Other
Study Drug
  • Drug: Danicopan
  • Drug: Midazolam
  • Drug: Fexofenadine
  • Drug: Mycophenolate Mofetil
Date
Apr 2017 - Jun 2017
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 60 Years years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Healthy was defined as having no clinically relevant abnormalities identified by a detailed medical history, physical examination, blood pressure and heart rate measurements, 12-lead electrocardiogram, and clinical laboratory tests.
  • Body mass index of 18.5 to 32 kilograms (kg)/square meter with a minimum body weight of 50 kg.
Exclusion Criteria
  • Mentally or legally incapacitated or significant emotional problems.
  • Any condition that might interfere with drug absorption.
  • History of sensitivity to study medication or other drug allergies.
  • Body temperature greater than or equal to 38°Celsius on Day -1 or Day 1 predose; history of febrile illness within 14 days of the first dose.
  • Positive urine drug test; current tobacco/nicotine users and smokers; consumption of alcohol within 72 hours of study drug administration.
  • Participated in another clinical study within 28 days prior to the first dose.
  • Significant laboratory abnormalities.
  • Blood donation of more than 500 milliliters within 3 months of the first dose; received a blood transfusion or blood products within 6 months to the first dose.

Protocol Summary

The purpose of this study was to determine the potential drug interaction between danicopan (ACH-0144471) and midazolam, fexofenadine, and mycophenolate mofetil. This was a 3-part study, with each part being an open-label, fixed-sequence, 2-treatment study in healthy adult participants.

Trial Locations

Location
Status
Location
Clinical Trial Site
Auckland, New Zealand
Status
N/A