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



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 75
Updated:4/26/2017
Start Date:October 2014
End Date:March 2016

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A Randomized, Placebo Controlled, Phase1 Study to Assess the Safety and Pharmacokinetics of GMI-1271 in Healthy Adult Subjects

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.

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 leukocyte and platelet activation of GMI-1271, an E-selectin antagonist,
in healthy volunteers.

Inclusion Criteria:

- 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 Criteria:

- 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.
We found this trial at
1
site
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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from
Ann Arbor, MI
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