Healthy Volunteers
Conditions
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-selectin antagonist, in healthy volunteers.
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 leukocyte and platelet activation of GMI-1271, an E-selectin antagonist, in healthy volunteers.
Interventions
Sponsors
University of Michigan
GlycoMimetics Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events as a measure of safety and tolerability | 14-19 days | Adverse Event data review |
| Type of adverse events as a measure of safety and tolerability | 14-19 days | Adverse Event data review |
| Severity of adverse events as a measure of safety and tolerability | 14-19 days | Adverse Event data review |
| Review of lab results as a measure of Pharmacokinetics | 3-5 days | Cmax (mg/mL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of bleeding | 14-19 days | Adverse Event data review |
Countries
United States
Outcome results
None listed