Healthy, Renal Impairment
Conditions
Keywords
Renal Insufficiency
Brief summary
The purpose of this study is to determine the effect of renal impairment on rivipansel.
Interventions
DRUGRivipansel
A single 840mg dose of Rivipansel over 20 minutes
Sponsors
GlycoMimetics Incorporated
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of laboratory tests | Baseline up to 96 hours |
| 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 |
| 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 |
| Physical examination | Baseline up to 96 hours |
| Assessment of adverse events | Baseline up to 28 days |
| Assessment of 12-lead electrocardiograms | Baseline up to 96 hours |
| Assessment of vital signs | Baseline up to 96 hours |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
United States
Outcome results
None listed