Study of Danicopan in Participants With Hepatic Impairment

Study Identifier:
ACH471-012
ClinicalTrials.gov Identifier:
NCT03555539
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete

Study Details

Medical Condition
  • Metabolism & Nutrition - Other
Study Drug
  • Drug: Danicopan
Date
May 2018 - Sep 2018
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 75 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Body mass index range of 18.0 to 40.0 kilograms (kg)/square meter with a minimum body weight of 50 kg at Screening.
  • Females must be of non-childbearing potential.
  • Males must agree to abstinence or use a highly effective method of contraception.
  • HI Participants:
  • Be sufficiently healthy for study participation.
  • Diagnosis of chronic (\>6 months) stable hepatic insufficiency.
  • A stable medication regimen.
  • In good general health at Screening and check-in, allowing for the concurrent illnesses associated with HI.
  • Evidence of cirrhosis due to hepatitis C virus (HCV), hepatitis B virus (HBV) infection, cryptogenic, alcohol abuse, or nonalcoholic steatohepatitis.
  • No evidence of hepatocellular carcinoma.
  • Have HI as assessed by a Child-Pugh classification score at Screening.
  • Healthy Participants:
  • Participants must be demographically matched to a hepatically impaired participant.
  • Medically healthy and without a clinically significant medical history.
Exclusion Criteria
  • Evidence of any other clinically significant deviation from normal in a clinical laboratory for the match-controlled participants and laboratory findings beyond those that are consistent with the degree of HI from hepatic participants.
  • History of any medical or psychiatric condition or disease.
  • Any previous procedure that could alter the absorption or excretion of orally administered drugs.
  • Body temperature greater than or equal to 38 degrees centigrade on Day -1 or Day 1 prior to dosing; history of febrile illness or other evidence of infection within 14 days prior to dosing.
  • History or presence of drug or alcohol abuse within 6 months prior to dosing; current tobacco/nicotine user; positive for alcohol and/or drugs-of-abuse at Screening or check in.
  • Participants who have received eculizumab at any dose or interval within the past 75 days.
  • Participation in any other investigational study drug trial 30 days before dosing.
  • Donation of whole blood from 3 months before dosing or of plasma from 30 days before dosing; receipt of blood products within 6 months before dosing.
  • HI Participants:
  • Any acute or chronic non-hepatic condition that would limit the participant's ability to participate in this study.
  • Any other unspecified reason that would make the participant unsuitable for enrollment.
  • Any screening laboratory evaluation outside the laboratory reference ranges not related to HI.
  • Fluctuating or rapidly deteriorating hepatic function within the screening period and up to 30 days prior to Day 1.
  • History of chronic liver disease due to Wilson's disease.
  • History of liver or other solid organ transplants.
  • Healthy Participants:
  • Clinical laboratory evaluations outside of the reference range at Screening or check-in.
  • Evidence of acute or chronic liver disease.
  • Use of any prescription medications/products within 14 days prior to dosing.
  • Use of over-the-counter, nonprescription preparations within 7 days prior to dosing.
  • Evidence of chronic HBV or chronic HCV infection.
Sex
Female & Male
Age
18 - 75 Years

Study Details

Medical Condition
  • Metabolism & Nutrition - Other
Study Drug
  • Drug: Danicopan
Date
May 2018 - Sep 2018
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 75 Years years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Body mass index range of 18.0 to 40.0 kilograms (kg)/square meter with a minimum body weight of 50 kg at Screening.
  • Females must be of non-childbearing potential.
  • Males must agree to abstinence or use a highly effective method of contraception.
  • HI Participants:
  • Be sufficiently healthy for study participation.
  • Diagnosis of chronic (\>6 months) stable hepatic insufficiency.
  • A stable medication regimen.
  • In good general health at Screening and check-in, allowing for the concurrent illnesses associated with HI.
  • Evidence of cirrhosis due to hepatitis C virus (HCV), hepatitis B virus (HBV) infection, cryptogenic, alcohol abuse, or nonalcoholic steatohepatitis.
  • No evidence of hepatocellular carcinoma.
  • Have HI as assessed by a Child-Pugh classification score at Screening.
  • Healthy Participants:
  • Participants must be demographically matched to a hepatically impaired participant.
  • Medically healthy and without a clinically significant medical history.
Exclusion Criteria
  • Evidence of any other clinically significant deviation from normal in a clinical laboratory for the match-controlled participants and laboratory findings beyond those that are consistent with the degree of HI from hepatic participants.
  • History of any medical or psychiatric condition or disease.
  • Any previous procedure that could alter the absorption or excretion of orally administered drugs.
  • Body temperature greater than or equal to 38 degrees centigrade on Day -1 or Day 1 prior to dosing; history of febrile illness or other evidence of infection within 14 days prior to dosing.
  • History or presence of drug or alcohol abuse within 6 months prior to dosing; current tobacco/nicotine user; positive for alcohol and/or drugs-of-abuse at Screening or check in.
  • Participants who have received eculizumab at any dose or interval within the past 75 days.
  • Participation in any other investigational study drug trial 30 days before dosing.
  • Donation of whole blood from 3 months before dosing or of plasma from 30 days before dosing; receipt of blood products within 6 months before dosing.
  • HI Participants:
  • Any acute or chronic non-hepatic condition that would limit the participant's ability to participate in this study.
  • Any other unspecified reason that would make the participant unsuitable for enrollment.
  • Any screening laboratory evaluation outside the laboratory reference ranges not related to HI.
  • Fluctuating or rapidly deteriorating hepatic function within the screening period and up to 30 days prior to Day 1.
  • History of chronic liver disease due to Wilson's disease.
  • History of liver or other solid organ transplants.
  • Healthy Participants:
  • Clinical laboratory evaluations outside of the reference range at Screening or check-in.
  • Evidence of acute or chronic liver disease.
  • Use of any prescription medications/products within 14 days prior to dosing.
  • Use of over-the-counter, nonprescription preparations within 7 days prior to dosing.
  • Evidence of chronic HBV or chronic HCV infection.

Protocol Summary

The purpose of this study was to evaluate the safety, tolerability, and pharmacokinetics (PK) of ACH-0144471 (danicopan) in participants with hepatic impairment (HI) as compared to healthy matched participants.

Trial Locations

Location
Status
Location
Clinical Trial Site
Miami, Florida, United States, 33136
Status
N/A
Location
Clinical Trial Site
Orlando, Florida, United States, 32809
Status
N/A