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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01941511

Run by

GlycoMimetics Incorporated

People needed

48

Starts

2013-08-01

Expected to finish

2014-08-01

Last updated by the study team

2020-06-18

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy African-American male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive.

You may not qualify if…

• 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).

Where it is running

• Pfizer Investigational Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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