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Study of Danicopan in Participants With Normal Kidney Function and Participants With Kidney Dysfunction | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT04935294•Alexion Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Body mass index (BMI) in the range of 18.0 to 40.0 kilograms (kg)/meter squared, inclusive, with a minimum body weight of 50 kg at screening.
•Stable creatinine clearance.
•Participants with RI must have met the following additional criteria to be enrolled in this study
•A stable medication regimen was required. Concomitant medications must have been approved by the Sponsor and Investigator (or designee) or pre-specified in the protocol.
•Abnormal laboratory values must not have been clinically relevant at screening or check-in.
•Participants were in good general health at screening and check-in, allowing for the concurrent illnesses associated with chronic kidney disease.
•Stable severe RI.
•Healthy matched control participants with normal renal function must have met the following additional criteria to be enrolled in this study
•In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram, and vital sign measurements at screening or check-in, as determined by the Investigator (or designee).
•Participants had normal renal function.
+1 more criteria

Exclusion Criteria

•History of any medical or psychiatric condition or disease (aside from RI for RI participants) that might have limited the participant's ability to complete or participate in this clinical study, confound the results of the study, or pose an additional risk to the participant by their participation in the study.
•History of procedures that could alter absorption or excretion of orally administered drugs.
•Body temperature ≥ 38°Celsius on Day - 1 or Day 1 predose; history of febrile illness, or other evidence of infection, within 14 days prior to study drug administration.
•History or presence of drug or alcohol abuse within previous year; current tobacco/nicotine user; positive for alcohol and/or drug screen at screening.
•Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives (if known) or 30 days prior to check-in, whichever was longer.
•For matched control participants, use of any prescription medications/products within 14 days prior to check-in and use of any over-the-counter, nonprescription preparations within 7 days prior to check-in, unless deemed acceptable by the Investigator (or designee).
•Donation of whole blood from 3 months prior to study drug administration, or of plasma from 30 days prior to study drug administration; receipt of blood products within 6 months prior to check-in.
•Participant required dialysis within the last 3 months prior to check-in.
•Participant did not produce sufficient urine output to permit urine sampling at screening and/or check-in; history of urinary incontinence prior to check-in.
•History of kidney transplant or actively on a transplant waiting list prior to check-in.
+2 more criteria

Locations (4)

Clinical Trial Site

Miami, Florida, United States

Clinical Trial Site

Orlando, Florida, United States

Clinical Trial Site

Minneapolis, Minnesota, United States

Clinical Trial Site

Saint Paul, Minnesota, United States

Key Dates

Start Date

January 24, 2018

Primary Completion Date

May 29, 2018

Completion Date

May 29, 2018

Last Updated

June 23, 2021

Enrollment

ACTUAL participants

Conditions

HealthyRenal Dysfunction

Interventions

Danicopan

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 23, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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