Trial record 2 of 4 for:    glycomimetics

Placebo-controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of GMI-1271 in Healthy Volunteers

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by GlycoMimetics Incorporated
Sponsor:
Information provided by (Responsible Party):
GlycoMimetics Incorporated
ClinicalTrials.gov Identifier:
NCT02168595
First received: June 17, 2014
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of single ascending IV doses of GMI-1271 in healthy adult subjects.


Condition Intervention Phase
Healthy Adult Subjects
Drug: GMI-1271
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Intravenous Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GMI-1271 in Healthy Adult Subjects

Further study details as provided by GlycoMimetics Incorporated:

Primary Outcome Measures:
  • Treatment related adverse events [ Time Frame: Day 1-15 ] [ Designated as safety issue: Yes ]
    Treatment related adverse events as a measure of safety and tolerability of GMI-1271 (time frame: Day 1-15)


Secondary Outcome Measures:
  • Time of peak plasma concentration (Tmax) [ Time Frame: Day 1-3 ] [ Designated as safety issue: No ]
  • Pharmacodynamics [ Time Frame: Day 1-3 ] [ Designated as safety issue: No ]
    WBC count, biomarkers to assess pharmacodynamics of single IV dose of GMI-1271 (time frame: Day 1-3)

  • Peak plasma concentration (Cmax) [ Time Frame: Day 1-3 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration vs time curve (AUC) [ Time Frame: Day 1-3 ] [ Designated as safety issue: No ]

Estimated Enrollment: 28
Study Start Date: June 2014
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
2 mg/kg GMI-1271 or matching placebo
Drug: GMI-1271
GMI-1271 is a potent, rationally designed glycomimetic E-selectin antagonist
Drug: Placebo
Experimental: Cohort 2
5 mg/kg GMI-1271 or matching placebo
Drug: GMI-1271
GMI-1271 is a potent, rationally designed glycomimetic E-selectin antagonist
Drug: Placebo
Experimental: Cohort 3
10 mg/kg GMI-1271 or matching placebo
Drug: GMI-1271
GMI-1271 is a potent, rationally designed glycomimetic E-selectin antagonist
Drug: Placebo

Detailed Description:

This is a randomized, double-blind, placebo-controlled, single ascending IV dose study conducted at one study center in the United States (US). One (1) cohort of 12 subjects (6 active and 6 placebo) and two (2) cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation. Subjects will participate in only one cohort. Safety will be assessed throughout the study and serial blood samples and urine samples will be collected for the safety and PK assessment of GMI-1271.

  Eligibility

Ages Eligible for Study:   19 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy adult male and/or females, 19 to 60 years of age, inclusive.
  2. Medically healthy with no clinically significant screening results (e.g., laboratory profiles, medical histories, vital signs, ECGs, physical examination) as deemed by the PI.
  3. Females of childbearing potential must either be sexually inactive (abstinent) for 3 months prior to dosing or be using an acceptable birth control method
  4. Females must have a negative pregnancy test at the time of screening and prior to dosing for inclusion in the study.
  5. Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.

Exclusion Criteria:

  1. Subject is mentally or legally incapacitated or has significant emotional problems at the time of screening visit or expected during the conduct of the study.
  2. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI.
  3. History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
  4. Hemoglobin level below the lower limit of normal at screening or check-in.
  5. Any liver function test (e.g., AST, ALT, bilirubin) 1.5x the upper limit of normal at screening or check-in.
  6. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV).
  7. Seated blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg at screening.
  8. Heart rate is lower than 40 bpm or higher than 99 bpm at screening.
  9. QTc interval >430 msec for males or >450 msec for females, or history of prolonged QT syndrome.
  10. Estimated creatinine clearance < 90 ml/min at screening or check-in.
  11. Blood donation or significant blood loss within 56 days prior to dosing.
  12. Plasma donation within 7 days prior to dosing.
  13. Participation in another clinical trial within 28 days prior to dosing. The 28-day window will be derived from the date of the last study procedure (such as last blood collection or dosing) in the previous study to Day 1 of Period 1 of the current study.

Note: If an increase (>1.5 x N) in bilirubin is present at screening additional liver function tests may be performed (such as ALT, AST, ALP, albumin, and direct and indirect bilirubin) to determine if the increase of bilirubin is due to Gilbert-Meulengracht syndrome. If consistent with Gilbert's syndrome, the Investigator and Sponsor may decide not to consider this as an exclusion. Any such decision will be documented in the study record.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02168595

Contacts
Contact: Barbara Cook, MD 402-437-6361 barbara.cook@celerion.com

Locations
United States, Nebraska
Celerion Recruiting
Lincoln, Nebraska, United States, 68502
Principal Investigator: Barbara Cook, MD         
Sponsors and Collaborators
GlycoMimetics Incorporated
Investigators
Principal Investigator: Barbara Cook, MD Celerion
  More Information

No publications provided

Responsible Party: GlycoMimetics Incorporated
ClinicalTrials.gov Identifier: NCT02168595     History of Changes
Other Study ID Numbers: GMI-1271-101
Study First Received: June 17, 2014
Last Updated: June 19, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by GlycoMimetics Incorporated:
healthy volunteers, GMI-1271

ClinicalTrials.gov processed this record on August 20, 2014