A Study to Evaluate the Effect of IV Doses of Gmi-1070 on Qtc Intervals in Healthy African-American Adult Subjects
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 11/30/2013 |
| Start Date: | August 2013 |
| End Date: | November 2013 |
| Contact: | Pfizer CT.gov Call Center |
| Phone: | 1-800-718-1021 |
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
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.
Safety
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).
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