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

Healthy Volunteers Clinical Trial

Official title:

A Randomized, Placebo Controlled, Phase1 Study to Assess the Safety and Pharmacokinetics of GMI-1271 in Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02271113
• Other study ID #: GMI-1271-102
• Status: Completed
• Phase: Phase 1
• First received: October 8, 2014
• Last updated: February 23, 2018
• Start date: October 2014
• Est. completion date: March 2016

Study information

• Verified date: February 2018
• Source: GlycoMimetics Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• GMI-1271

• Placebo

• Enoxaparin Sodium (Lovenox®)

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
GlycoMimetics Incorporated	University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events as a measure of safety and tolerability	Adverse Event data review	14-19 days
Primary	Type of adverse events as a measure of safety and tolerability	Adverse Event data review	14-19 days
Primary	Severity of adverse events as a measure of safety and tolerability	Adverse Event data review	14-19 days
Primary	Review of lab results as a measure of Pharmacokinetics	Cmax (mg/mL)	3-5 days
Primary	Review of lab results as a measure of Pharmacokinetics	AUC (mg/mL)	3-5 days
Secondary	Incidence of bleeding	Adverse Event data review	14-19 days