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Completed

NCT Number: NCT01941511

A Study to Evaluate the Effect of IV 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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

San Antonio, Texas, 78209, United States

About this study

Safety

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Rivipansel

Drug

Subjects will receive in a randomized sequence rivipansel 4gA IV, moxifloxacin 400 mg, and placebo IV.

Other names: GMI-1070

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

GlycoMimetics Incorporated

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 13, 2013
Registry last updated
Jun 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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