This study is being conducted to evaluate the safety and tolerability of treatment with CTP-499 in non-dialysis patients associated with moderate chronic kidney disease.
This study will evaluate the safety and tolerability of treatment with CTP-499 starting with 600 milligrams (mg) once a day (QD) for 2 weeks followed by 600 mg twice a day (BID) for 2 weeks in non-dialysis patients associated with moderate chronic kidney disease defined as an estimated Glomerular Filtration Rate or eGFR that is 30-59 mL/min/1.73m2
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
33
West Coast Clinical Trials
Costa Mesa, California, United States
Southern California Clinical Research
Garden Grove, California, United States
Orange County Research Center
Tustin, California, United States
Safety measures
number of adverse events, vital signs, ECGs, clinical laboratory measures and physical exams
Time frame: 4 weeks
Pharmacokinetic Profile
Time Frame: Predose, 0, 1, 2, 3, 4, 6, 8, 12, 18, 24 hours Cmax, Tmax, Area Under the Curve (AUC)
Time frame: 4 weeks
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