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

GlycoMimetics

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: GMI-1271; Drug: Enoxaparin Sodium (Lovenox®); Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02271113

GMI-1271-102

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

32 participants in 3 patient groups, including a placebo group

GMI-1271

Experimental group

Description:

IV GMI-1271

Treatment:

Drug: GMI-1271

Placebo

Placebo Comparator group

Description:

IV Placebo

Treatment:

Drug: Placebo

Enoxaparin Sodium (Lovenox®)

Active Comparator group

Description:

SC Lovenox®

Treatment:

Drug: Enoxaparin Sodium (Lovenox®)