Clinical trial NCT02271113: Phase I Study to Assess Safety and Pharmacokinetics of GMI-1271 in Healthy Adult Subjects
Official title: A Randomized, Placebo Controlled, Phase1 Study to Assess the Safety and Pharmacokinetics of GMI-1271 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: GlycoMimetics Incorporated
Sponsor class: INDUSTRY
Collaborators: name: University of Michigan
First posted: 2014-10-22
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Number of adverse events as a measure of safety and tolerability
timeFrame: 14-19 days
measure: Type of adverse events as a measure of safety and tolerability
timeFrame: 14-19 days
measure: Severity of adverse events as a measure of safety and tolerability
timeFrame: 14-19 days
measure: Review of lab results as a measure of Pharmacokinetics
timeFrame: 3-5 days
measure: Review of lab results as a measure of Pharmacokinetics
timeFrame: 3-5 days
Secondary outcomes:
measure: Incidence of bleeding
timeFrame: 14-19 days
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Suman Sood, MD
role: PRINCIPAL_INVESTIGATOR
References: