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

NCT ID: NCT02271113

Last Updated: 2018-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2016-03-31

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

GMI-1271

IV GMI-1271

Group Type: EXPERIMENTAL

GMI-1271

Intervention Type: DRUG

Placebo

IV Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Enoxaparin Sodium (Lovenox®)

SC Lovenox®

Group Type: ACTIVE_COMPARATOR

Enoxaparin Sodium (Lovenox®)

Intervention Type: DRUG

Interventions

GMI-1271

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Enoxaparin Sodium (Lovenox®)

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Michigan

OTHER

Sponsor Role: collaborator

GlycoMimetics Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suman Sood, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

GMI-1271-102

Identifier Type: -

Identifier Source: org_study_id