Study of Danicopan in Participants With Hepatic Impairment
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Part 1: Healthy Match Single 200-milligram (mg) dose of danicopan on Day 1 in healthy participants (matched control group with normal hepatic function). |
Drug: Danicopan
Oral tablet.
Other Names:
|
Experimental: Part 1: Moderate HI Single 200-mg dose of danicopan on Day 1 in participants with moderate HI. |
Drug: Danicopan
Oral tablet.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Area Under The Plasma Concentration Versus Time Curve From Time 0 Extrapolated To Infinity (AUC0-inf) Of Danicopan [Up to 72 hours postdose]
- Area Under The Plasma Concentration Versus Time Curve From Time 0 To The Last Measurable Concentration (AUC0-t) Of Danicopan [Up to 72 hours postdose]
- Maximum Observed Plasma Concentration (Cmax) Of Danicopan [Up to 72 hours postdose]
- Time To Maximum Observed Plasma Concentration (Tmax) Of Danicopan [Up to 72 hours postdose]
Secondary Outcome Measures
- Participants Experiencing Treatment-emergent Adverse Events [Day 1 (postdose) through follow-up visit (10 [+/- 2] days after last study drug administration)]
Eligibility Criteria
Criteria
Key Inclusion Criteria:
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Body mass index range of 18.0 to 40.0 kilograms (kg)/square meter with a minimum body weight of 50 kg at Screening.
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Females must be of non-childbearing potential.
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Males must agree to abstinence or use a highly effective method of contraception.
HI Participants:
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Be sufficiently healthy for study participation.
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Diagnosis of chronic (>6 months) stable hepatic insufficiency.
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A stable medication regimen.
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In good general health at Screening and check-in, allowing for the concurrent illnesses associated with HI.
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Evidence of cirrhosis due to hepatitis C virus (HCV), hepatitis B virus (HBV) infection, cryptogenic, alcohol abuse, or nonalcoholic steatohepatitis.
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No evidence of hepatocellular carcinoma.
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Have HI as assessed by a Child-Pugh classification score at Screening.
Healthy Participants:
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Participants must be demographically matched to a hepatically impaired participant.
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Medically healthy and without a clinically significant medical history.
Key Exclusion Criteria:
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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.
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History of any medical or psychiatric condition or disease.
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Any previous procedure that could alter the absorption or excretion of orally administered drugs.
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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.
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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.
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Participants who have received eculizumab at any dose or interval within the past 75 days.
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Participation in any other investigational study drug trial 30 days before dosing.
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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:
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Any acute or chronic non-hepatic condition that would limit the participant's ability to participate in this study.
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Any other unspecified reason that would make the participant unsuitable for enrollment.
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Any screening laboratory evaluation outside the laboratory reference ranges not related to HI.
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Fluctuating or rapidly deteriorating hepatic function within the screening period and up to 30 days prior to Day 1.
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History of chronic liver disease due to Wilson's disease.
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History of liver or other solid organ transplants.
Healthy Participants:
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Clinical laboratory evaluations outside of the reference range at Screening or check-in.
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Evidence of acute or chronic liver disease.
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Use of any prescription medications/products within 14 days prior to dosing.
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Use of over-the-counter, nonprescription preparations within 7 days prior to dosing.
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Evidence of chronic HBV or chronic HCV infection.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Clinical Trial Site | Miami | Florida | United States | 33136 |
2 | Clinical Trial Site | Orlando | Florida | United States | 32809 |
Sponsors and Collaborators
- Alexion Pharmaceuticals
- Achillion, a wholly owned subsidiary of Alexion
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ACH471-012