Study of Intravenous GMI-1070 in Adults With Sickle Cell Disease

May 7, 2020 updated by: GlycoMimetics Incorporated

Phase 1/Phase 2 Study of the Safety, Pharmacokinetics, and Microvascular Effect of Titrating Doses of Intravenous GMI-1070, a Pan-Selectin Inhibitor, in Adults With Sickle Cell Disease

This Phase 1/Phase 2 study will evaluate GMI-1070, a pan-selectin inhibitor, in adults with stable sickle cell disease. The study will assess safety, pharmacokinetics, and microvascular effects of intravenous GMI-1070 in the outpatient setting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2
  • 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
      • Oakland, California, United States, 94609
        • Children's Hospital & Research Center Oakland
      • Sacramento, California, United States, 95817
        • University of California at Davis, CCRC
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Comprehensive Sickle Cell 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

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 to 45 years
  • Established diagnosis of SCD-SS or SCD-SB0-thal
  • At medical baseline, with no evidence of worsening of disease over the last 3 months
  • Available and agree to return for follow-up visits for the full duration of the study
  • Able to cooperate with study procedures
  • Documented and observed written informed consent

Exclusion Criteria:

  • Vaso-occlusive crisis
  • Recent major surgery, hospitalization, infection, significant bleeding, cerebrovascular accident or seizure, or transfusion
  • Currently receiving, or has received within the previous 4 weeks, any other investigational agent
  • Pregnant or lactating female; or female of childbearing age unable or unwilling to comply with birth control or abstinence during the course of the study

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GMI-1070
Drug: GMI-1070
Intravenous GMI-1070 given as two doses over the course of one day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety as Measured by the Number of Participants With Adverse Events
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Total Plasma Clearance
Time Frame: 48 hours
48 hours
Volume of the Central Compartment
Time Frame: 48 hours
48 hours
Intercompartmental Clearance
Time Frame: 48 hours
48 hours
Volume of the Peripheral Compartment
Time Frame: 48 hours
48 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Flow and Biomarkers of Adhesion
Time Frame: 48 hours
As an exploratory outcome mean change in microvascular blood flow from baseline to each time point was measured. Microvascular blood flow was also measured as microFI, perfused vessel density, and RBC velocity.
48 hours

Collaborators and Investigators

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

Sponsor

GlycoMimetics Incorporated

Investigators

  • Study Director: Helen Thackray, MD, 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

May 1, 2009

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

May 27, 2009

First Submitted That Met QC Criteria

May 29, 2009

First Posted (Estimate)

June 2, 2009

Study Record Updates

Last Update Posted (Actual)

May 11, 2020

Last Update Submitted That Met QC Criteria

May 7, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GMI-1070-103

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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