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A Study to Evaluate the Effect of IV Doses of Rivipansel on Subjects With Renal Impairment and in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02813798
Recruitment Status : Completed
First Posted : June 27, 2016
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
GlycoMimetics Incorporated

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

Condition or disease Intervention/treatment Phase
Renal Impairment Healthy Drug: Rivipansel Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A PHASE 1, NON-RANDOMIZED, OPEN-LABEL, SINGLE DOSE STUDY TO EVALUATE THE EFFECT OF RENAL IMPAIRMENT ON THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF RIVIPANSEL (PF-06460031) IN SUBJECTS WITH RENAL IMPAIRMENT AND IN HEALTHY SUBJECTS
Actual Study Start Date : June 2016
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2018

Arm Intervention/treatment
Experimental: Mild Renal Impairment
A single dose of IV Rivipansel over 20 minutes
Drug: Rivipansel
A single 840mg dose of Rivipansel over 20 minutes
Other Name: GMI-1070

Experimental: Moderate Renal Impairment
A single dose of IV Rivipansel over 20 minutes
Drug: Rivipansel
A single 840mg dose of Rivipansel over 20 minutes
Other Name: GMI-1070

Experimental: Severe Renal Impairment
A single dose of IV Rivipansel over 20 minutes
Drug: Rivipansel
A single 840mg dose of Rivipansel over 20 minutes
Other Name: GMI-1070

Experimental: Normal Renal Functions
A single dose of IV Rivipansel over 20 minutes
Drug: Rivipansel
A single 840mg dose of Rivipansel over 20 minutes
Other Name: GMI-1070




Primary Outcome Measures :
  1. 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 [ Time Frame: 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 ]
  2. Clearance (CL) [ Time Frame: 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 ]
  3. Renal clearance [ Time Frame: 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 ]
  4. Physical examination [ Time Frame: Baseline up to 96 hours ]
  5. Assessment of adverse events [ Time Frame: Baseline up to 28 days ]
  6. Assessment of 12-lead electrocardiograms [ Time Frame: Baseline up to 96 hours ]
  7. Assessment of vital signs [ Time Frame: Baseline up to 96 hours ]
  8. Assessment of laboratory tests [ Time Frame: Baseline up to 96 hours ]

Secondary Outcome Measures :
  1. Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration [ Time Frame: 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 ]
  2. Peak or maximum observed concentration [ Time Frame: 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 ]
  3. Time to reach maximum concentration [ Time Frame: 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 ]
  4. Terminal half life [ Time Frame: 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 ]
  5. Apparent volume of distribution [ Time Frame: 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 ]
  6. Amount of unchanged drug excreted into urine over 96 hours [ Time Frame: 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 ]
  7. Percentage of dose excreted unchanged into urine over 96 hours [ Time Frame: 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 ]
  8. Fraction of unbound [ Time Frame: 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813798


Locations
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United States, California
Anaheim Clinical Trials, LLC
Anaheim, California, United States, 92801
United States, Florida
Avail Clinical Research, LLC
DeLand, Florida, United States, 32720
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
Sponsors and Collaborators
GlycoMimetics Incorporated
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
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Responsible Party: GlycoMimetics Incorporated
ClinicalTrials.gov Identifier: NCT02813798    
Other Study ID Numbers: B5201005
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlycoMimetics Incorporated:
Renal Insufficiency
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases