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

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ClinicalTrials.gov Identifier: NCT02271113
Recruitment Status : Completed
First Posted : October 22, 2014
Last Update Posted : February 27, 2018
Sponsor:
Collaborator:
University of Michigan
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: GMI-1271 Drug: Placebo Drug: Enoxaparin Sodium (Lovenox®) Phase 1

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  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: A Randomized, Placebo Controlled, Phase1 Study to Assess the Safety and Pharmacokinetics of GMI-1271 in Healthy Adult Subjects
Actual Study Start Date : October 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

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®)



Primary Outcome Measures :
  1. Number of adverse events as a measure of safety and tolerability [ Time Frame: 14-19 days ]
    Adverse Event data review

  2. Type of adverse events as a measure of safety and tolerability [ Time Frame: 14-19 days ]
    Adverse Event data review

  3. Severity of adverse events as a measure of safety and tolerability [ Time Frame: 14-19 days ]
    Adverse Event data review

  4. Review of lab results as a measure of Pharmacokinetics [ Time Frame: 3-5 days ]
    Cmax (mg/mL)

  5. Review of lab results as a measure of Pharmacokinetics [ Time Frame: 3-5 days ]
    AUC (mg/mL)


Secondary Outcome Measures :
  1. Incidence of bleeding [ Time Frame: 14-19 days ]
    Adverse Event data review



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02271113


Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
GlycoMimetics Incorporated
University of Michigan
Investigators
Principal Investigator: Suman Sood, MD University of Michigan

Responsible Party: GlycoMimetics Incorporated
ClinicalTrials.gov Identifier: NCT02271113     History of Changes
Other Study ID Numbers: GMI-1271-102
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Enoxaparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action