Safety, Tolerability and Pharmacokinetics of KBP-5074 in Healthy Subjects and Subjects With Renal Impairment
- Registration Number
- NCT02653014
- Lead Sponsor
- KBP Biosciences
- Brief Summary
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.
- Detailed Description
This study consists of two parts: Part 1 is an open-label, multiple ascending dose (MAD) study to evaluate the safety, tolerability and pharmacokinetics of KBP-5074 in healthy subjects. The safety and tolerability will be assessed at each dose level before progressing to the next higher dose. Part 2 is an open label, randomized, parallel study to assess the safety and tolerability, the effect of renal dysfunction on the pharmacokinetics of KBP-5074, as well as the PK/PD relationship in subjects with mild to moderate renal impairment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1 KBP-5074 Healthy Volunteers will receive 2.5mg of KBP-5074, QD, 14 days Cohort 2 KBP-5074 Healthy Volunteers will receive 5.0mg of KBP-5074, QD, 14 days Cohort 3 KBP-5074 Subjects with mild to moderate renal impairment will receive 0.5mg of KBP-5074, QD, 56 days Cohort 4 KBP-5074 Subjects with mild to moderate renal impairment will receive 2.5mg of KBP-5074, QD, 56 days
- Primary Outcome Measures
Name Time Method Safety and tolerability Up to 69 days Rate of adverse events
- Secondary Outcome Measures
Name Time Method The effect of mild to moderate renal impairment on the Area Under Curve (AUC) Up to 15 days AUC 0-24 hours
Area Under Curve (AUC) in healthy subjects pre-dose and 2, 4, 6, 8, 10, 12, 18, and 24 hours post dose on Day 1; pre-dose on Days 8, 11, 12, and 13; and pre-dose and 2, 4, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 168, 216, 264, and 312 hours post dose on Day 14 AUC 0-24 hours
Area Under Curve (AUC) in subjects with mild to moderate renal impairment pre-dose and 2, 4, 6, 8, 10, 12, 18, and 24 hours post dose on Day 1; pre-dose on Days 8, 11, 12, and 13; pre-dose and 2, 4, 6, 8, 10, 12, 18, and 24 hours post dose on Day 14; pre-dose on Days 29 and 43; and pre-dose and 6, 12, and 24 hours on Day 56 AUC 0-24 hours
Plasma aldosterone levels in healthy subjects Pre-dose, 6, and 24 hours post dose on Day 1; pre-dose on Day 8; and 24 hours post last dose on Day 15 Plasma aldosterone level
Serum potassium levels in healthy subjects Pre-dose, 6, and 24 hours post dose on Day 1; pre-dose on Day 8; and 24 hours post last dose on Day 15 Serum potassium level
Plasma aldosterone levels in subjects with mild to moderate renal impairment Pre-dose, 6, and 24 hours post dose on Day 1; pre-dose on Days 8, 15, 29, and 43; and 24 hours post last dose on Day 57 Plasma aldosterone level
Serum potassium levels in subjects with mild to moderate renal impairment Pre-dose, 6, and 24 hours post dose on Day 1; pre-dose on Days 8, 15, 29, and 43; and 24 hours post last dose on Day 57 Serum potassium level
Urinary Albumin to Creatinine Ratio (UACR) in subjects with mild to moderate renal impairment Pre-dose, 6, and 24 hours post dose on Day 1; pre-dose on Days 8, 15, 29, and 43; and 24 hours post last dose on Day 57 Ratio of urinary albumin level to creatinine level
Blood Pressure in subjects with mild to moderate renal impairment Pre-dose, 6, and 24 hours post dose on Day 1; pre-dose on Days 8, 15, 29, and 43; and 24 hours post last dose on Day 57 Systolic and diastolic seated blood pressure
Trial Locations
- Locations (1)
Research by Design, LLC
🇺🇸Evergreen Park, Illinois, United States