Skip to main content
OpenTrials
Completed

NCT Number: NCT03555539

Study of Danicopan in Participants With Hepatic Impairment

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Trial Site, Miami, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Danicopan

Drug

Oral tablet.

Other names: ALXN2040, ACH-0144471 (formerly), ACH-4471, ACH4471, 4471

Primary outcomes

  1. Area Under The Plasma Concentration Versus Time Curve From Time 0 Extrapolated To Infinity (AUC0-inf) Of Danicopan

    Time frame: Up to 72 hours postdose

  2. Area Under The Plasma Concentration Versus Time Curve From Time 0 To The Last Measurable Concentration (AUC0-t) Of Danicopan

    Time frame: Up to 72 hours postdose

  3. Maximum Observed Plasma Concentration (Cmax) Of Danicopan

    Time frame: Up to 72 hours postdose

  4. Time To Maximum Observed Plasma Concentration (Tmax) Of Danicopan

    Time frame: Up to 72 hours postdose

Secondary outcomes

  1. Participants Experiencing Treatment-emergent Adverse Events

    Time frame: Day 1 (postdose) through follow-up visit (10 [+/- 2] days after last study drug administration)

Sponsors and collaborators

Lead sponsor

Alexion Pharmaceuticals, Inc.

Industry

Collaborators

  • Achillion, a wholly owned subsidiary of Alexion

Registry information

Official study title

A Phase 1, 2-Part, Open-Label, Single-Dose, Parallel Group Study to Determine the Effect of Hepatic Impairment on the Safety, Tolerability, and Pharmacokinetics of ACH-0144471 in Adult Subjects

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 13, 2018
Registry last updated
Aug 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.