NCT02271113

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Oct 2014

Longer than P75 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 22, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

February 27, 2018

Status Verified

February 1, 2018

Enrollment Period

1.4 years

First QC Date

October 8, 2014

Last Update Submit

February 23, 2018

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (1)

  • Incidence of bleeding

    14-19 days

Study Arms (3)

GMI-1271

EXPERIMENTAL

IV GMI-1271

Drug: GMI-1271

Placebo

PLACEBO COMPARATOR

IV Placebo

Drug: Placebo

Enoxaparin Sodium (Lovenox®)

ACTIVE COMPARATOR

SC Lovenox®

Drug: Enoxaparin Sodium (Lovenox®)

Interventions

GMI-1271DRUG
GMI-1271
PlaceboDRUG
Placebo
Enoxaparin Sodium (Lovenox®)DRUG
Enoxaparin Sodium (Lovenox®)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Interventions

uproleselanenoxaparin sodiumEnoxaparin

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Suman Sood, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2014

First Posted

October 22, 2014

Study Start

October 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

February 27, 2018

Record last verified: 2018-02

Locations

US(1)