Phase I Study to Assess Safety and Pharmacokinetics of GM... | NCT02271113

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

NCT02271113

Sponsor

GlycoMimetics Incorporated

Status

Completed

Last Update Posted

Feb 27, 2018Actual

Enrollment

32Actual

Phase

Phase 1

Conditions

Healthy Volunteers

Interventions

GMI-1271
Placebo
Enoxaparin Sodium (Lovenox®)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014Actual

Primary Completion Date

Mar 2016Actual

Completion Date

Mar 2016Actual

First Submitted Date

Oct 8, 2014

First Submission Date that Met QC Criteria

Oct 20, 2014

First Posted Date

Oct 22, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 23, 2018

Last Update Posted Date

Feb 27, 2018Actual

Name	Class
University of Michigan	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
GMI-1271	Drug		GMI-1271
Placebo

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
C000654285	uproleselan
C000711671	enoxaparin sodium
D017984	Enoxaparin

ID	Term
D006495	Heparin, Low-Molecular-Weight
D006493	Heparin
D006025	Glycosaminoglycans
D011134	Polysaccharides