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Completed

NCT Number: NCT02813798

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

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

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Key information

Conditions

Renal Impairment Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Healthy Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anaheim Clinical Trials, LLC, Anaheim, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivipansel

Drug

A single 840mg dose of Rivipansel over 20 minutes

Other names: GMI-1070

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

GlycoMimetics Incorporated

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 27, 2016
Registry last updated
Jun 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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