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

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ClinicalTrials.gov Identifier: NCT01941511
Recruitment Status : Completed
First Posted : September 13, 2013
Last Update Posted : September 5, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Rivipansel Phase 1

Detailed Description:
Safety

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Official 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
Study Start Date : August 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


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 Name: GMI-1070




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01941511


Locations
United States, Texas
Pfizer Investigational Site
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01941511     History of Changes
Other Study ID Numbers: B5201001
B5201001
First Posted: September 13, 2013    Key Record Dates
Last Update Posted: September 5, 2014
Last Verified: September 2014

Keywords provided by Pfizer:
QTc
African-American
GMI-1070
QT/QTc interval prolongation

Additional relevant MeSH terms:
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs