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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02813798
Other study ID # B5201005
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date June 2016
Est. completion date February 2018

Study information

Verified date June 2020
Source GlycoMimetics Incorporated
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the effect of renal impairment on rivipansel.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date February 2018
Est. primary completion date February 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Rivipansel
A single 840mg dose of Rivipansel over 20 minutes

Locations

Country Name City State
United States Anaheim Clinical Trials, LLC Anaheim California
United States Avail Clinical Research, LLC DeLand Florida
United States Orlando Clinical Research Center Orlando Florida

Sponsors (1)

Lead Sponsor Collaborator
GlycoMimetics Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary Physical examination Baseline up to 96 hours
Primary Assessment of adverse events Baseline up to 28 days
Primary Assessment of 12-lead electrocardiograms Baseline up to 96 hours
Primary Assessment of vital signs Baseline up to 96 hours
Primary Assessment of laboratory tests Baseline up to 96 hours
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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