Type 2 Diabetics, Chronic Kidney Disease, Protein in Urine Clinical Trial
Official title:
A Phase 1b, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a Single-Dose of ABT-614 and the Effect of ABT-614 on Glomerular Filtration Rate in Subjects With Type 2 Diabetes and Chronic Kidney Disease With Albuminuria
To assess the safety, tolerability and pharmacokinetics of ABT-614 in subjects with type 2 diabetes and chronic kidney disease with albuminuria and to determine whether ABT-614 reduces glomerular filtration rate.
This Phase 1b, single-site, double-blind, randomized, placebo-controlled study will be
conducted in three Periods; Baseline, Dosing and Outpatient. Eligible adult male and female
subjects with type 2 diabetes and CKD (chronic kidney disease) with albuminuria will be
selected to participate.
Eighteen subjects will be selected to participate in the Baseline Period to ensure that 16
subjects are enrolled in the Dosing Period. Subjects who are eligible from Screening will be
confined to the study site beginning on Day -2 (the day before the Baseline Period
infusion). On Day -1, subjects will be administered an iothalamate infusion to measure
baseline GFR (glomerular filtration rate). Subjects who continue to be eligible on Day 1
will be randomized in a 1:1 ratio to receive either a 10 mg dose of ABT-614 or matching
placebo daily, for 15 days.
On Day 15 subjects will be administered a second iothalamate infusion. Plasma and urine
samples for ABT-614 and iothalamate will be collected. Subjects will be released from
confinement on Day 20 after the completion of all study procedures including the 120-hour
blood sample collection. Thereafter, subjects will return for outpatient visits on Days 25
and 30 as well as 30 days after the last dose of study drug. A ± 2 day window will be
permitted on the 30-day Follow-up Visit to accommodate subject scheduling.
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment