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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Notify MeKey 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
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
Primary outcomes
-
Pharmacokinetics variable - Area under the plasma concentration curve
Time frame: Time zero through 96 hours
Secondary outcomes
-
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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