study of danicopan in participants with hepatic impairment

Conditions: Hepatic Impairment

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.


Eligibility criteria:
key 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. key 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.

Keywords: hepatic impairment danicopan alxn2040 ach-0144471 pharmacokinetics factor d inhibitor safety