A Study to Evaluate the Effect of IV Doses of Rivipansel on Subjects With Renal Impairment and in Healthy Subjects
- Registration Number
- NCT02813798
- Lead Sponsor
- GlycoMimetics Incorporated
- Brief Summary
The purpose of this study is to determine the effect of renal impairment on rivipansel.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
Inclusion Criteria
- Female subjects of non-childbearing potential or male subjects
- Body Mass Index (BMI) of 17.5 to 40.0 kg/m2
- Stable renal function
Exclusion Criteria
- A positive urine drug screen for illicit drugs
- Treatment with an investigational drug within 30 days of the dose of study medication
- Pregnant females, breastfeeding female subjects and male subjects with partners currently pregnant
- Use of herbal supplements in the 28 days prior to the dose of study medication
- Blood donation (excluding plasma donation) of approximately 1 pint or more within 56 days prior to study medication
- Requiring dialysis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Moderate Renal Impairment Rivipansel A single dose of IV Rivipansel over 20 minutes Mild Renal Impairment Rivipansel A single dose of IV Rivipansel over 20 minutes Severe Renal Impairment Rivipansel A single dose of IV Rivipansel over 20 minutes Normal Renal Functions Rivipansel A single dose of IV Rivipansel over 20 minutes
- Primary Outcome Measures
Name Time Method Clearance (CL) Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration Renal clearance Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration Area under the concentration-time curve from time 0 to infinity or area under the concentration-time curve from time 0 to the time of the last quantifiable concentration, as data permit Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration Assessment of 12-lead electrocardiograms Baseline up to 96 hours Assessment of laboratory tests Baseline up to 96 hours Physical examination Baseline up to 96 hours Assessment of adverse events Baseline up to 28 days Assessment of vital signs Baseline up to 96 hours
- Secondary Outcome Measures
Name Time Method Apparent volume of distribution Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration Time to reach maximum concentration Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration Peak or maximum observed concentration Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration Terminal half life Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration Percentage of dose excreted unchanged into urine over 96 hours Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration Fraction of unbound Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration Amount of unchanged drug excreted into urine over 96 hours Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration
Trial Locations
- Locations (3)
Anaheim Clinical Trials, LLC
🇺🇸Anaheim, California, United States
Avail Clinical Research, LLC
🇺🇸DeLand, Florida, United States
Orlando Clinical Research Center
🇺🇸Orlando, Florida, United States