CLINICAL TRIALS PROFILE FOR KBP-5074
✉ Email this page to a colleague
Clinical Trials for KBP-5074
| Trial ID | Title | Status | Sponsor | Phase | Summary |
|---|---|---|---|---|---|
| NCT02228733 ↗ | Phase 1 Single Ascending Dose Study to Evaluate Safety, Tolerability and Pharmacokinetics of KBP-5074 | Completed | KBP Biosciences | Phase 1 | This single ascending dose (SAD) study in healthy subjects will evaluate the safety, tolerability and pharmacokinetics of KBP-5074. PK/PD (plasma aldosterone, serum potassium and urine albumin levels) relationships will be explored to support the selection of dosing regimens of KBP-5074 that are suitable for the Phase 2 dose-finding study to evaluate the efficacy, safety and tolerability of KBP-5074 in patients that could slow the progression of nephropathy as well as control hypertension. |
| NCT02653014 ↗ | Safety, Tolerability and Pharmacokinetics of KBP-5074 in Healthy Subjects and Subjects With Renal Impairment | Completed | KBP Biosciences | Phase 1/Phase 2 | This multiple ascending dose (MAD) study in healthy subjects and subjects with mild to moderate renal impairment will evaluate the safety, tolerability and pharmacokinetics of KBP-5074. Safety/tolerability data and Pharmacokinetics (PK)/Pharmacodynamics (PD) (plasma aldosterone, serum potassium, UACR and Blood Pressure) relationships will be explored to support the selection of dosing regimens of KBP-5074 that are suitable for the Phase II/III study. |
| NCT02837237 ↗ | Safety, Tolerability, and Pharmacokinetics of KBP-5074 Following Oral Administration in Chronic Kidney Disease | Completed | KBP Biosciences | Phase 1/Phase 2 | This study explores the use of KBP-5074 in patients with advanced stages of Chronic Kidney Disease (CKD) (including patients with severe renal impairment and those on hemodialysis [HD]) and to assess the safety, tolerability, and pharmacokinetics (PK) of single doses of KBP-5074 in male and female patients with severe CKD (defined as estimated glomerular filtration rate [eGFR] ≥15 mL/min/1.73 m2 and ≤29 mL/min/1.73 m2, based on the Modification of Diet in Renal Disease [MDRD] equation) and a subset of patients requiring HD. |
| NCT03340753 ↗ | Bioavailability of KBP-5074 Tablet vs Capsule Formulations | Unknown status | Medpace, Inc. | Phase 1 | This is an open-label, partial crossover, single-dose study to evaluate the pharmacokinetics (PK), dose proportionality, and safety/tolerability of tablet versus capsule formulations of KBP-5074 in healthy subjects. The study is designed to evaluate the PK of a new tablet formulation versus that of the current capsule formulation. Data derived from this study, in addition to preclinical data and chemistry, manufacturing, and controls, will provide a basis for dose selection in future studies. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
Clinical Trial Conditions for KBP-5074
Condition Name
Clinical Trial Locations for KBP-5074
Trials by Country
Clinical Trial Progress for KBP-5074
Clinical Trial Phase
Clinical Trial Sponsors for KBP-5074
Sponsor Name
