Phase I Study to Assess Safety and Pharmacokinetics of GMI-1271 in Healthy Adult Subjects

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

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-selectin antagonist, in healthy volunteers.

Key facts

Study ID

NCT02271113

Run by

GlycoMimetics Incorporated

People needed

32

Starts

2014-10-01

Expected to finish

2016-03-01

Last updated by the study team

2018-02-27

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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