NCT04935294

Study of Danicopan in Participants With Normal Kidney Function and Participants With Kidney Dysfunction

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy
• Renal Dysfunction

Interventions

Type	Name	Description
DRUG	Danicopan	Oral tablet.

Timeline

• Start date: 2018-01-24
• Primary completion: 2018-05-29
• Completion: 2018-05-29
• First posted: 2021-06-23
• Last updated: 2021-06-23

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study