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

NCT01941511 | Completed Phase 1

• 1 other identifier: B5201001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• QTc, during moxifloxacin treatment period

  prior to dose, through 72 hours after dosing

Study Arms (1)

Rivipansel/Placebo/Moxifloxacin

EXPERIMENTAL

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

Interventions

Rivipansel DRUG

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

Also known as: GMI-1070

Rivipansel/Placebo/Moxifloxacin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy African-American male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive.

You may not qualify if:

• 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).

Sponsors & Collaborators

• GlycoMimetics Incorporated: lead

Study Sites (1)

Pfizer Investigational Site

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Interventions

rivipansel

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2013
• First Posted: September 13, 2013
• Study Start: August 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: June 18, 2020

Record last verified: 2020-06

Locations

US (1)