Status:
COMPLETED
Phase I Study to Assess Safety and Pharmacokinetics of GMI-1271 in Healthy Adult Subjects
Lead Sponsor:
GlycoMimetics Incorporated
Collaborating Sponsors:
University of Michigan
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
In this study, the investigators will evaluate the safety, pharmacokinetics and effect on target biomarkers of coagulation, cell adhesion, and leukocyte and platelet activation of GMI-1271, an E-selec...
Detailed Description
Investigators will evaluate in a single ascending dose (SAD) and multiple ascending dose (MAD) fashion, the safety, pharmacokinetics and effect on target biomarkers of coagulation, cell adhesion, and ...
Eligibility Criteria
Inclusion
- Age 18-75 years
- Male or female
- Medically healthy, as defined by the absence of clinically significant screening results (e.g. laboratory profile, medical history, electrocardiogram (ECG), physical examination)
- BMI 18-35 kg/m2
- Voluntary consent to participate in the study
- No evidence of Lower Extremity Deep Vein Thrombosis (LE DVT) at baseline by ultrasound
Exclusion
- Use of any prescription, investigational, herbal, supplemental, or over the counter medications including aspirin within 14 days (for the SAD phase) and 7 days (for the MAD phase) prior to day 1 or unwilling/unable to refrain from the use of these medications on days 1-8 for the SAD phase and days 1-12 of the MAD phase of the study
- Previous administration of GMI-1271
- Positive drug testing at screening and baseline or positive alcohol testing at baseline or unwilling/unable to refrain from the use of drugs or alcohol on days 1-8 for the SAD phase and days 1-12 for the MAD phase of the study
- Pregnant or breastfeeding
- Unwilling or unable to use contraception during the time of participation in the trial and 14 days afterwards (sexual abstinence is permissible)
- Positive HIV, Hepatitis B surface antigen or Hepatitis C antibody at screening
- Hypersensitivity or allergic reaction to compounds related to GMI-1271
- Use of moderate caffeine (≥ 300 mg/day) within 48 hours prior to dosing (day 1)
- History of bleeding disorder
- Any liver function test \> 1.5 times upper limit of normal or renal insufficiency with creatinine clearance \< 30 ml/min.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT02271113
Start Date
October 1 2014
End Date
March 1 2016
Last Update
February 27 2018
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109