A Study to Evaluate the Effect of IV Doses of GMI-1070 on Qtc Intervals in Healthy African-American Adult Subjects

Study Overview
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Brief Summary
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This is a clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential of GMI-1070 in African-American Adult subjects. This is conducted as part of standard drug development.

Detailed Description
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Safety

Official Title
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A Phase 1, Randomized, 3-way, Crossover Single Dose, Placebo, and Active Controlled Study to Evaluate the Effect of Intravenous Doses of GMI-1070 on Qtc Intervals in Healthy African-American Adult Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Rivipansel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy African-American male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive. Exclusion Criteria: Pregnant females; breastfeeding females; and females of childbearing potential. Males who are unwilling or unable to use 2 highly effective method of contraception for the duration of the study starting at least 14 days prior to the first dose of investigational product and for at least 28 days after the last dose of investigational product. Non African-American. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic,seasonal allergies at the time of dosing).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rivipansel/Placebo/Moxifloxacin<br>Rivipansel 4.8 gA IV infusion over 20 minutes Phosphate Buffered Saline (PBS) IV infusion over 20 minutes Moxifloxacin (Avelox) 400 mg single oral dose | Drug: Rivipansel<br>* Subjects will receive in a randomized sequence rivipansel 4gA IV, moxifloxacin 400 mg, and placebo IV.<br>* Other names: GMI-1070;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QTc, during rivipansel treatment period | QTc, using Fridericia's correction method (QTcF) at each time point during rivipansel treatment period. | prior to dose, through 72 hours after dosing | 
| QTc, during placebo treatment period | QTc, using Fridericia's correction method (QTcF) at each time point during placebo treatment period. | prior to dose, through 72 hours after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QTc, during moxifloxacin treatment period | QTcF, or any other appropriate correction method at each postdose time point of moxifloxacin treatment. | prior to dose, through 72 hours after dosing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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QTc, African-American, GMI-1070, QT/QTc interval prolongation