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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mast Therapeutics, Inc.

Criteria

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