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OpenTrials
Completed

NCT Number: NCT02646358

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

DaVita Clinical Research, Lakewood, Colorado, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vepoloxamer

Drug

Primary outcomes

  1. Pharmacokinetics variable - Area under the plasma concentration curve

    Time frame: Time zero through 96 hours

Secondary outcomes

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v.4.03

    Time frame: Time zero through Day 14

Sponsors and collaborators

Lead sponsor

Mast Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
First posted
Jan 5, 2016
Registry last updated
Dec 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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