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

Mast Therapeutics, Inc.1 site in 1 country27 target enrollmentStarted: January 2016Last updated: December 22, 2016

Conditions

Interventions

Drugs

Trial Snapshot

Phase: Phase 1
Status: Completed
Sponsor: Mast Therapeutics, Inc.
Enrollment: 27
Locations: 1
Primary Endpoint: Pharmacokinetics variable - Area under the plasma concentration curve

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief 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.

Study Design

Study Type: Interventional
Allocation: Non Randomized
Intervention Model: Single Group
Masking: None

Eligibility Criteria

Ages: 18 Years to 75 Years (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: Yes

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

Exclusion Criteria

Not provided