Safety, Tolerability and Pharmacokinetics of KBP-5074 in Healthy Subjects and Subjects With Renal… (NCT02653014) | Clinical Trial Compass
CompletedPhase 1
Safety, Tolerability and Pharmacokinetics of KBP-5074 in Healthy Subjects and Subjects With Renal Impairment
United States26 participantsStarted 2015-07-29
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria for Part 1:
* Healthy male or female subject
* Are between the ages of 18 and 45 years (inclusive);
* Body mass index (BMI) of 19 to 30 kg/m2 inclusive and body weight not less than 50 kg.
Exclusion Criteria for Part 1:
* Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity;
* Known or suspected malignancy;
* Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C (HCV) antibody;
* Positive pregnancy test result.
Inclusion Criteria for Part 2:
* Are between the ages of 18 and 75 years (inclusive);
* Mild to moderate chronic kidney disease (defined as estimated glomerular filtration rate (eGFR) \> 30 and ≤89 mL/min/1.73 m2, using the modification of diet in renal disease (MDRD) formula, for \> 3 months;
* Proteinuria (defined as urine albumin to creatinine ratio (UACR) ≥100 mg/g and ≤3,000 mg/g in two mid-morning urine specimens within a month interval);
* Subjects treated with an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB)
* Serum potassium≥3.3 mmol/L and ≤4.8 mmol/L;
* Body mass index (BMI) of 19 to 40 kg/m2 inclusive and body weight not less than 50 kg.
Exclusion Criteria for Part 2:
* Severe uncontrolled hypertension (diastolic \> 115 mmHg or systolic blood pressure \> 180…