A Study to Evaluate the Effect of IV Doses of Rivipansel in Subjects With Moderate Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function
NCT ID: NCT02871570
Last Updated: 2020-07-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
16 participants
INTERVENTIONAL
2016-09-30
2017-03-31
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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Moderate Hepatic Impairment
A single dose of IV Rivipansel over 20 minutes
Rivipansel
A single dose of IV Rivipansel over 20 minutes
Normal Hepatic Function
A single dose of IV Rivipansel over 20 minutes
Rivipansel
A single dose of IV Rivipansel over 20 minutes
Interventions
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Rivipansel
A single dose of IV 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
* Normal Hepatic function for the healthy subjects
* Stable Hepatic Impairment for the subjects with moderate hepatic impairment
Exclusion Criteria
* 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
* A positive urine drug screen for illicit drugs
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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Orlando Clincial 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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B5201006
Identifier Type: -
Identifier Source: org_study_id
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