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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Placebo; Drug: GMI-1271; Drug: Enoxaparin Sodium (Lovenox®)

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GMI-1271; IV GMI-1271	Drug: GMI-1271
Placebo Comparator: Placebo; IV Placebo	Drug: Placebo
Active Comparator: Enoxaparin Sodium (Lovenox®); SC Lovenox®	Drug: Enoxaparin Sodium (Lovenox®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adverse events as a measure of safety and tolerability	Adverse Event data review	14-19 days
Type of adverse events as a measure of safety and tolerability	Adverse Event data review	14-19 days
Severity of adverse events as a measure of safety and tolerability	Adverse Event data review	14-19 days
Review of lab results as a measure of Pharmacokinetics	Cmax (mg/mL)	3-5 days
Review of lab results as a measure of Pharmacokinetics	AUC (mg/mL)	3-5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of bleeding	Adverse Event data review	14-19 days

Collaborators and Investigators

• Sponsor: GlycoMimetics Incorporated
• Collaborators: University of Michigan
• Investigators: Principal Investigator: Suman Sood, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: October 8, 2014
• First Submitted That Met QC Criteria: October 20, 2014
• First Posted (Estimate): October 22, 2014

Study Record Updates

• Last Update Posted (Actual): February 27, 2018
• Last Update Submitted That Met QC Criteria: February 23, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Enoxaparin; Enoxaparin sodium
• Other Study ID Numbers: GMI-1271-102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No