A Study to Evaluate the Effect of IV Doses of GMI-1070 on Qtc Intervals in Healthy African-American Adult Subjects
NCT01941511
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Adult Trials: 18+ Years
- Healthy African-American male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive.
- 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).
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | A Study to Evaluate the Effect of IV Doses of GMI-1070 on Qtc Intervals in Healthy African-American Adult Subjects | |||
| Official Title ICMJE | 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 | |||
| 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 | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 1 | |||
| Study Design ICMJE | Intervention Model: Crossover Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Other | |||
| Condition ICMJE | Healthy | |||
| Intervention ICMJE | Drug: Rivipansel
Subjects will receive in a randomized sequence rivipansel 4gA IV, moxifloxacin 400 mg, and placebo IV. Other Name: GMI-1070 | |||
| Study Arms ICMJE | 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 Intervention: Drug: Rivipansel | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 48 | |||
| Original Estimated Enrollment ICMJE | 42 | |||
| Actual Study Completion Date ICMJE | August 2014 | |||
| Actual Primary Completion Date | August 2014 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years to 55 Years (Adult) | |||
| Accepts Healthy Volunteers ICMJE | Yes | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01941511 | |||
| Other Study ID Numbers ICMJE | B5201001 B5201001 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | GlycoMimetics Incorporated | |||
| Study Sponsor ICMJE | GlycoMimetics Incorporated | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | GlycoMimetics Incorporated | |||
| Verification Date | June 2020 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||