Danicopan
DrugOral tablet.
Other names: ALXN2040, ACH-0144471 (formerly), ACH-4471, ACH4471, 4471
NCT Number: NCT04935294
This was an open-label, nonrandomized, multi-center, single-dose, parallel group study to evaluate the effect of severe renal impairment (RI) on the safety, tolerability, pharmacokinetics, and pharmacodynamics of danicopan (ACH-0144471) compared to demographically-matched healthy participants with normal renal function.
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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:
Participants with RI must have met the following additional criteria to be enrolled in this study
Healthy matched control participants with normal renal function must have met the following additional criteria to be enrolled in this study
Key Exclusion Criteria:
Oral tablet.
Other names: ALXN2040, ACH-0144471 (formerly), ACH-4471, ACH4471, 4471
Time frame: Day 1 through Day 10 (+/- 2 days)
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: Baseline, Up to 72 hours postdose
Time frame: Baseline, Up to 72 hours postdose
Alexion Pharmaceuticals, Inc.
Industry
A Phase I, Open-Label, Parallel Group Study To Evaluate ACH-0144471 Safety, Tolerability, And Pharmacokinetics In Subjects With Normal Renal Function And Subjects With Renal Dysfunction
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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