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

Sickle Cell Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00911495
• Other study ID #: GMI-1070-103
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 2009
• Est. completion date: September 2010

Study information

• Verified date: May 2020
• Source: GlycoMimetics Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

Drug:
• GMI-1070
Intravenous GMI-1070 given as two doses over the course of one day

Locations

Country	Name	City	State
United States	Duke Comprehensive Sickle Cell Center	Durham	North Carolina
United States	Children's Hospital & Research Center Oakland	Oakland	California
United States	University of California at Davis, CCRC	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
GlycoMimetics Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood Flow and Biomarkers of Adhesion	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
Primary	Safety as Measured by the Number of Participants With Adverse Events		28 days
Secondary	Total Plasma Clearance		48 hours
Secondary	Volume of the Central Compartment		48 hours
Secondary	Intercompartmental Clearance		48 hours
Secondary	Volume of the Peripheral Compartment		48 hours