Danicopan
DrugOral tablet.
Other names: ALXN2040, ACH-0144471 (formerly), ACH-4471, ACH4471, 4471
NCT Number: NCT03555539
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.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 1
Clinical Trial Site, Miami, Florida, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
HI Participants:
Healthy Participants:
Key Exclusion Criteria:
HI Participants:
Healthy Participants:
Oral tablet.
Other names: ALXN2040, ACH-0144471 (formerly), ACH-4471, ACH4471, 4471
Time frame: Up to 72 hours postdose
Time frame: Up to 72 hours postdose
Time frame: Up to 72 hours postdose
Time frame: Up to 72 hours postdose
Time frame: Day 1 (postdose) through follow-up visit (10 [+/- 2] days after last study drug administration)
Alexion Pharmaceuticals, Inc.
Industry
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
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.
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