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
NCT02871570
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FOR MORE INFORMATION
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- Female subjects of non-childbearing potential or male subjects
- 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
- 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
- A positive urine drug screen for illicit drugs
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Descriptive Information | ||||
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Brief Title ICMJE | 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 | |||
Official Title ICMJE | A Phase 1, Non-randomized, Open-label, Parallel-group Single-dose Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Intravenous Rivipansel (Pf-06460031) In Subjects With Moderate Hepatic Impairment And In Healthy Subjects With Normal Hepatic Function | |||
Brief Summary | The purpose of this study is to determine the effect of hepatic impairment on rivipansel PK and safety. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Other | |||
Condition ICMJE |
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Intervention ICMJE | Drug: Rivipansel
A single dose of IV Rivipansel over 20 minutes Other Name: GMI-1070 | |||
Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 16 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | March 2017 | |||
Actual Primary Completion Date | February 2017 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02871570 | |||
Other Study ID Numbers ICMJE | B5201006 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | GlycoMimetics Incorporated | |||
Study Sponsor ICMJE | GlycoMimetics Incorporated | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | GlycoMimetics Incorporated | |||
Verification Date | June 2020 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |