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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02646358

Enrollment

Registered

2016-01-05

Start date

2016-01-31

Completion date

Unknown

Last updated

2016-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers, Pharmacokinetics of Vepoloxamer, Renal Impaired

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.

Interventions

DRUGVepoloxamer

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics variable - Area under the plasma concentration curve	Time zero through 96 hours

Secondary

Measure	Time frame
Number of participants with treatment-related adverse events as assessed by CTCAE v.4.03	Time zero through Day 14

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026