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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01941511

Enrollment

Registered

2013-09-13

Start date

2013-08-31

Completion date

2014-08-31

Last updated

2020-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

QTc, African-American, GMI-1070, QT/QTc interval prolongation

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

Interventions

DRUGRivipansel

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

Study design

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	Time frame	Description
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.
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.

Secondary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026