A Study to Evaluate the Effect of IV Doses of GMI-1070 on Qtc Intervals in Healthy African-American Adult Subjects
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|ClinicalTrials.gov Identifier: NCT01941511|
Recruitment Status : Completed
First Posted : September 13, 2013
Last Update Posted : September 5, 2014
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Rivipansel||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||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|
|Study Start Date :||August 2013|
|Primary Completion Date :||August 2014|
|Study Completion Date :||August 2014|
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
Subjects will receive in a randomized sequence rivipansel 4gA IV, moxifloxacin 400 mg, and placebo IV.
Other Name: GMI-1070
- QTc, during rivipansel treatment period [ Time Frame: prior to dose, through 72 hours after dosing ]QTc, using Fridericia's correction method (QTcF) at each time point during rivipansel treatment period.
- QTc, during placebo treatment period [ Time Frame: prior to dose, through 72 hours after dosing ]QTc, using Fridericia's correction method (QTcF) at each time point during placebo treatment period.
- QTc, during moxifloxacin treatment period [ Time Frame: prior to dose, through 72 hours after dosing ]QTcF, or any other appropriate correction method at each postdose time point of moxifloxacin treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01941511
|United States, Texas|
|Pfizer Investigational Site|
|San Antonio, Texas, United States, 78209|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|