Study of the Effect of Renal Impairment on the Pharmacokinetics of Vepoloxamer



Status:Recruiting
Conditions:Healthy Studies, Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology, Other
Healthy:No
Age Range:18 - 75
Updated:4/21/2016
Start Date:January 2016

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A Phase 1, Open-Label, Non-Randomized Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Vepoloxamer in Subjects With Varying Degrees of Renal Impairment and Healthy Matched Control Subjects With Normal Renal Function

This is an open-label study designed to evaluate the effect of renal disease on the
pharmacokinetics of vepoloxamer relative to the pharmacokinetics in healthy subjects with
normal renal function.


Key Inclusion Criteria:

- Subject must weigh ≤ 125 kg and have a body mass index between 20 and 40 kg/m2

- Subject must be willing to be confined in the clinical research unit for the duration
of the study, up to 5 days

- If female, subject must not be pregnant or lactating, have a negative pregnancy test,
and agrees to sexual abstinence, or use of an appropriate birth control method from
screening through 30 days after study drug administration

- If male, subject agrees to sexual abstinence, is surgically sterile, or is using an
appropriate birth control method from screening through 30 days after study drug
administration

- Considered by the Investigator to be healthy or clinically stable with respect to
underlying renal impairment based on medical evaluation including vital signs, ECG
and laboratory test results

- Non-smoker, or smokes fewer than 10 cigarettes/day

Key Exclusion Criteria

- Uncontrolled medical condition (treated or untreated) considered to be clinically
significant by the Investigator

- Experienced an illness considered by the Investigator to be clinically significant
within 2 weeks of study drug administration

- Treatment with another investigational drug or device study within 30 days or 5
half-lives (whichever is longer) prior to screening

- Positive test for drugs of abuse and/or positive alcohol test at Screening or Day -1

- Donated or lost a significant volume of blood or plasma within 90 days prior to study
drug administration
We found this trial at
2
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Lakewood, Colorado 80228
Phone: 855-327-7833
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825 South 8th Street
Minneapolis, Minnesota 55404
888-345-2567
Phone: 855-327-7833
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Minneapolis, MN
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