Clinical Trials Logo

Clinical Trial Summary

Phase 1 - Pharmacokinetics in Patients with Impaired Renal Function


Clinical Trial Description

The study is a two-center, Phase 1, open-label, single-dose, one-period, four-parallel-group, PK study in subjects with various severities of renal dysfunction and healthy volunteers. Subjects will be categorized in 4 groups: Group 1: subjects with mild renal impairment Group 2: subjects with moderate renal impairment Group 3: subjects with severe renal impairment Group 4 (control group): subjects with normal renal function The mild (group 1) and moderate (group 2) patients with renal disease will be dosed first, in a parallel fashion. At this point, interim PK analyses will be performed and a safety committee composed of Sponsor and Contract Research Organization (CRO) members will jointly review the PK data before dosing the patients with severe renal disease (group 3). Control subjects (group 4) will be recruited after the recruitment of groups 1 to 3. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03776539
Study type Interventional
Source Eloxx Pharmaceuticals, Inc.
Contact
Status Completed
Phase Phase 1
Start date January 4, 2019
Completion date August 7, 2019

See also
  Status Clinical Trial Phase
Terminated NCT04252430 - RI Study to Assess and Compare the Pharmacokinetic Parameters of MD1003 in Renal Impaired Patients and Healthy Subjects Phase 1
Completed NCT01716455 - Study of SSP-004184 (FBS0701) in Healthy Adults and Elderly Subjects and in Subjects With Impaired Renal Function Phase 1
Completed NCT02431481 - Evaluation of Renal Function Impairment on the Pharmacokinetics of LEE011 Phase 1
Completed NCT02087566 - Linezolid Pharmacokinetics In Patients With Impaired Renal Function (PPT6) N/A
Completed NCT04179630 - Study of Aldafermin (NGM282) in Participants With Impaired Renal Function Phase 1
Completed NCT00779922 - Pharmacokinetics of Lenalidomide (Revlimid®) in Patients With Multiple Myeloma and Impaired Renal Function Phase 2
Completed NCT00784381 - Computer Prescribing System and Impaired Renal Function Phase 3
Completed NCT01507350 - Effects of Obesity Surgery on Renal Function
Active, not recruiting NCT01760031 - Longterm Follow-up After Remote Ischemic Preconditioning for Prevention of Contrast-induced Nephropathy N/A
Completed NCT01035320 - Platelet Function in Diabetic Patients With and Without Renal Impairment, and the Effects of Lipid Lowering Treatment Phase 4
Completed NCT00604357 - CNI-free de Novo Protocol in Patients Undergoing Liver Transplantation With Renal Impairment Phase 3
Completed NCT02965040 - A Phase 1 Study of Roxadustat in Subjects With Different Degrees of Renal Function Phase 1
Completed NCT00981045 - Evaluation of Efficacy and Safety of Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia and Impaired Renal Function Phase 3
Completed NCT02467478 - Linagliptin's Effect on CD34+ Stem Cells Phase 4
Recruiting NCT04620590 - An Open Label Phase IV Study to Evaluate Dapagliflozin Treatment in Type 2 Diabetes Mellitus Patients With Impaired Renal Function Phase 4