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

• Sponsor: GlycoMimetics Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02271113
• Collaborator: University of Michigan (Other)
• Enrollment: 32
• Location: 1
• Arms: 3
• Actual Duration (Months): 17
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Oct 1, 2014
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

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®)

Outcome Measures

Primary Outcome Measures

1. Number of adverse events as a measure of safety and tolerability [14-19 days]

   Adverse Event data review

2. Type of adverse events as a measure of safety and tolerability [14-19 days]

   Adverse Event data review

3. Severity of adverse events as a measure of safety and tolerability [14-19 days]

   Adverse Event data review

4. Review of lab results as a measure of Pharmacokinetics [3-5 days]

   Cmax (mg/mL)

5. Review of lab results as a measure of Pharmacokinetics [3-5 days]

   AUC (mg/mL)

Secondary Outcome Measures

1. Incidence of bleeding [14-19 days]

   Adverse Event data review

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GlycoMimetics Incorporated
• ClinicalTrials.gov Identifier: NCT02271113
• Other Study ID Numbers: GMI-1271-102
• First Posted: Oct 22, 2014
• Last Update Posted: Feb 27, 2018
• Last Verified: Feb 1, 2018

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Enoxaparin; Enoxaparin sodium

Study Results

No Results Posted as of Feb 27, 2018