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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

Tracking Information
First Submitted Date  ICMJE June 15, 2016
First Posted Date  ICMJE June 27, 2016
Last Update Posted Date June 18, 2020
Actual Study Start Date  ICMJE June 2016
Actual Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2016)
  • 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 ]
  • 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 ]
  • 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 ]
  • Physical examination [ Time Frame: Baseline up to 96 hours ]
  • Assessment of adverse events [ Time Frame: Baseline up to 28 days ]
  • Assessment of 12-lead electrocardiograms [ Time Frame: Baseline up to 96 hours ]
  • Assessment of vital signs [ Time Frame: Baseline up to 96 hours ]
  • Assessment of laboratory tests [ Time Frame: Baseline up to 96 hours ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 22, 2016)
  • 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, 48, 72 and 96 H following single dose administration ]
  • Clearance (CL) [ Time Frame: Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 48, 72 and 96 H following single dose administration ]
  • Renal clearance [ Time Frame: Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 48, 72 and 96 H following single dose administration ]
  • Physical examination [ Time Frame: Baseline up to 96 hours ]
  • Assessment of adverse events [ Time Frame: Baseline up to 96 hours ]
  • Assessment of 12-lead electrocardiograms [ Time Frame: Baseline up to 96 hours ]
  • Assessment of vital signs [ Time Frame: Baseline up to 96 hours ]
  • Assessment of laboratory tests [ Time Frame: Baseline up to 96 hours ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2016)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2016)
  • 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, 48, 72 and 96 H following single dose administration ]
  • Peak or maximum observed concentration [ Time Frame: Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 48, 72 and 96 H following single dose administration ]
  • Time to reach maximum concentration [ Time Frame: Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 48, 72 and 96 H following single dose administration ]
  • Terminal half life [ Time Frame: Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 48, 72 and 96 H following single dose administration ]
  • Apparent volume of distribution [ Time Frame: Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 48, 72 and 96 H following single dose administration ]
  • 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, 48, 72 and 96 H following single dose administration ]
  • 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, 48, 72 and 96 H following single dose administration ]
  • Fraction of unbound [ Time Frame: Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 48, 72 and 96 H following single dose administration ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Effect of IV Doses of Rivipansel on Subjects With Renal Impairment and in Healthy Subjects
Official Title  ICMJE 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
Brief Summary The purpose of this study is to determine the effect of renal impairment on rivipansel.
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
  • Renal Impairment
  • Healthy
Intervention  ICMJE Drug: Rivipansel
A single 840mg dose of Rivipansel over 20 minutes
Other Name: GMI-1070
Study Arms  ICMJE
  • Experimental: Mild Renal Impairment
    A single dose of IV Rivipansel over 20 minutes
    Intervention: Drug: Rivipansel
  • Experimental: Moderate Renal Impairment
    A single dose of IV Rivipansel over 20 minutes
    Intervention: Drug: Rivipansel
  • Experimental: Severe Renal Impairment
    A single dose of IV Rivipansel over 20 minutes
    Intervention: Drug: Rivipansel
  • Experimental: Normal Renal Functions
    A single dose of IV Rivipansel over 20 minutes
    Intervention: Drug: Rivipansel
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
 (submitted: June 22, 2016)
28
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2018
Actual Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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 NCT02813798
Other Study ID Numbers  ICMJE B5201005
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party GlycoMimetics Incorporated
Study Sponsor  ICMJE GlycoMimetics Incorporated
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
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