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

June 16, 2020 updated by: GlycoMimetics Incorporated

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92801
        • Anaheim Clinical Trials, LLC
    • Florida
      • DeLand, Florida, United States, 32720
        • Avail Clinical Research, LLC
      • Orlando, Florida, United States, 32809
        • Orlando Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • GMI-1070

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
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
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
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
Baseline up to 96 hours
Assessment of adverse events
Time Frame: Baseline up to 28 days
Baseline up to 28 days
Assessment of 12-lead electrocardiograms
Time Frame: Baseline up to 96 hours
Baseline up to 96 hours
Assessment of vital signs
Time Frame: Baseline up to 96 hours
Baseline up to 96 hours
Assessment of laboratory tests
Time Frame: Baseline up to 96 hours
Baseline up to 96 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlycoMimetics Incorporated

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 27, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B5201005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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