Study of ALXN2050 in Participants With Renal Impairment
NCT04623710 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2023-09-29
Summary
This study will investigate the impact of impaired renal function on the plasma pharmacokinetics of ALXN2050 in order to provide dosing recommendations for future indications in individuals with impaired renal function.
Conditions
- Renal Impairment
- Healthy
Interventions
- DRUG
-
ALXN2050
ALXN2050 (120 milligrams) will be administered orally twice daily on Days 1 through 3, with an additional dose (120 milligrams) administered orally on the morning of Day 4.
Sponsors & Collaborators
-
Alexion Pharmaceuticals, Inc.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-07-08
- Primary Completion
- 2022-02-18
- Completion
- 2022-03-21
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
A Study to Evaluate Pharmacokinetics (PK) and Safety of Inaxaplin in Participants With Renal Impairment
NCT05865171 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Effect of Renal Impairment on JNJ-42847922 in Adult Participants
NCT04616677 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of AL-335
NCT02894905 ·Status: COMPLETED ·Phase: PHASE1
-
PF-04634817 Renal Impairment Study
NCT01791855 ·Status: COMPLETED ·Phase: PHASE1
-
To Compare the Pharmacokinetics of Avanafil in Subjects With Mild and Moderate Renal Impairment to Subjects With Normal Renal Function.
NCT01054261 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics, Safety, and Tolerability of Methylnaltrexone (MNTX) in Subjects With Impaired Renal Function
NCT01367509 ·Status: COMPLETED ·Phase: PHASE1
-
A Pharmacokinetic Study of YM178 in Normal Subjects and Those With Mild, Moderate, and Severe Renal Impairment
NCT00750620 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluation of the Pharmacokinetics and Safety of VX-548 in Participants With Renal Impairment
NCT05704556 ·Status: COMPLETED ·Phase: PHASE1
-
PK Study of ACHN-490 Injection in Renally Impaired Subjects
NCT01462136 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Pharmacokinetics Study of MBX 2109 in Adult Subjects With Normal and Impaired Renal Function
NCT06496217 ·Status: COMPLETED ·Phase: PHASE1
-
A Renal Impairment Study for PF-04965842
NCT03660241 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate the Effects of Renal Impairment on the Pharmacokinetics, Safety and Tolerability of GC4419
NCT05412472 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of INCB054707 in Participants With Normal and Impaired Renal Function and Participants on Hemodialysis
NCT05624723 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy, Safety and Tolerability of Balcinrenone/Dapagliflozin Compared to Dapagliflozin in Adults With Chronic Kidney Disease
NCT06350123 ·Status: COMPLETED ·Phase: PHASE2
-
Open-Label, Single-Dose Study to Evaluate the Safety and PK of DIC075V in Subjects With Renal Insufficiency and Hepatic Impairment Compared to Healthy Subjects and Evaluate the Safety and Pharmacokinetics of HPβCD When Administered in DIC075V Compared to Sporanox® in Healthy Subjects
NCT00805090 ·Status: COMPLETED ·Phase: PHASE1
-
Study of ALXN1850 in Participants With Hypophosphatasia (HPP)
NCT04980248 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess the Tolerability and Efficacy of AKST1210 in Patients on Hemodialysis With Cognitive Impairment
NCT04527328 ·Status: COMPLETED ·Phase: NA
-
Study of the Oral Factor D (FD) Inhibitor ALXN2050 in PNH Patients as Monotherapy
NCT04170023 ·Status: TERMINATED ·Phase: PHASE2
-
To Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of KN060 in ESRD Dialysis Patients
NCT07201467 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Study to Investigate the Effects of AZD6140 in Patients With Renal Impairment and in Healthy Volunteers
NCT00733265 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Danicopan in Participants With Normal Kidney Function and Participants With Kidney Dysfunction
NCT04935294 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluate the Effect of ALLN-177 in Reducing Urinary Oxalate in Patients With Secondary Hyperoxaluria and Kidney Stones Over 28 Days
NCT02547805 ·Status: COMPLETED ·Phase: PHASE2
-
Dose-Escalation Study of ALXN1210 IV in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)
NCT02598583 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Pharmacokinetics, Safety and Tolerability of AGO178C in Subjects With Renal Deficiencies Compared With Healthy Subjects
NCT01459250 ·Status: COMPLETED ·Phase: PHASE1
-
An Investigational Study of ESK-001 in Participants With Normal Renal Function and Participants With Mild, Moderate, and Severe Impaired Renal Function
NCT06962774 ·Status: COMPLETED ·Phase: PHASE1