A Study to Evaluate the Effect of IV Doses of Rivipansel on Subjects With Renal Impairment and in Healthy Subjects
NCT ID: NCT02813798
Last Updated: 2020-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
28 participants
INTERVENTIONAL
2016-06-30
2018-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Mild Renal Impairment
A single dose of IV Rivipansel over 20 minutes
Rivipansel
A single 840mg dose of Rivipansel over 20 minutes
Moderate Renal Impairment
A single dose of IV Rivipansel over 20 minutes
Rivipansel
A single 840mg dose of Rivipansel over 20 minutes
Severe Renal Impairment
A single dose of IV Rivipansel over 20 minutes
Rivipansel
A single 840mg dose of Rivipansel over 20 minutes
Normal Renal Functions
A single dose of IV Rivipansel over 20 minutes
Rivipansel
A single 840mg dose of Rivipansel over 20 minutes
Interventions
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Rivipansel
A single 840mg dose of Rivipansel over 20 minutes
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body Mass Index (BMI) of 17.5 to 40.0 kg/m2
* Stable renal function
Exclusion Criteria
* 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
18 Years
75 Years
ALL
Yes
Sponsors
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GlycoMimetics Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Anaheim Clinical Trials, LLC
Anaheim, California, United States
Avail Clinical Research, LLC
DeLand, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
Countries
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References
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Tammara BK, Ryan K, Plotka A, Shafer FE, Wei H, Readett D, Fang A, Korth-Bradley JM. Effect of Renal or Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Intravenous Rivipansel. Clin Pharmacol Drug Dev. 2020 Nov;9(8):918-928. doi: 10.1002/cpdd.842. Epub 2020 Jun 24.
Other Identifiers
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B5201005
Identifier Type: -
Identifier Source: org_study_id
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