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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Rivipansel

Detailed Description

Safety

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78209
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rivipansel/Placebo/Moxifloxacin; 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; Subjects will receive in a randomized sequence rivipansel 4gA IV, moxifloxacin 400 mg, and placebo IV.; Other Names: GMI-1070

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: GlycoMimetics Incorporated

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: August 27, 2013
• First Submitted That Met QC Criteria: September 9, 2013
• First Posted (Estimate): September 13, 2013

Study Record Updates

• Last Update Posted (Actual): June 18, 2020
• Last Update Submitted That Met QC Criteria: June 16, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: African-American; QTc; GMI-1070; QT/QTc interval prolongation
• Other Study ID Numbers: B5201001