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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Placebo; Drug: Enoxaparin Sodium (Lovenox®); Drug: GMI-1271

• Registration Number: NCT02271113
• Lead Sponsor: GlycoMimetics Incorporated

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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-08
• Study First Submitted QC: 2014-10-20
• Study First Posted: 2014-10-22
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-23
• Last Update Posted: 2018-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	IV Placebo
Enoxaparin Sodium (Lovenox®)	Enoxaparin Sodium (Lovenox®)	SC Lovenox®
GMI-1271	GMI-1271	IV GMI-1271

Primary Outcome Measures

Name	Time	Method
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	AUC (mg/mL)

Secondary Outcome Measures

Name	Time	Method
Incidence of bleeding	14-19 days	Adverse Event data review

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States