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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Rivipansel

• Registration Number: NCT01941511
• Lead Sponsor: GlycoMimetics Incorporated

Brief Summary

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

Safety

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-27
• Study First Submitted QC: 2013-09-09
• Study First Posted: 2013-09-13
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-16
• Last Update Posted: 2020-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Rivipansel/Placebo/Moxifloxacin	Rivipansel	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

Primary Outcome Measures

Name	Time	Method
QTc, during placebo treatment period	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 rivipansel treatment period	prior to dose, through 72 hours after dosing	QTc, using Fridericia's correction method (QTcF) at each time point during rivipansel treatment period.

Secondary Outcome Measures

Name	Time	Method
QTc, during moxifloxacin treatment period	prior to dose, through 72 hours after dosing	QTcF, or any other appropriate correction method at each postdose time point of moxifloxacin treatment.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 San Antonio, Texas, United States