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Placebo-Controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of GMI-1359 in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02931214
Recruitment Status : Completed
First Posted : October 12, 2016
Last Update Posted : March 4, 2019
Sponsor:
Collaborator:
Celerion
Information provided by (Responsible Party):
GlycoMimetics Incorporated

Tracking Information
First Submitted Date  ICMJE September 6, 2016
First Posted Date  ICMJE October 12, 2016
Last Update Posted Date March 4, 2019
Actual Study Start Date  ICMJE August 2016
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2016)
Treatment related adverse events [ Time Frame: 15 days ]
Treatment related adverse events as a measure of safety and tolerability of GMI-1359
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2016)
  • Pharmacokinetics [ Time Frame: 48 hours ]
    Cmax (peak plasma concentration)
  • Pharmacokinetics [ Time Frame: 48 hours ]
    AUC (area under the curve)
  • Pharmacokinetics [ Time Frame: 48 hours ]
    Tmax (time to peak plasma concentration)
  • Pharmacodynamics [ Time Frame: 48 hours ]
    CD34 cell measurement
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Placebo-Controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of GMI-1359 in Healthy Volunteers
Official Title  ICMJE A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GMI-1359 in Healthy Adult Subjects
Brief Summary The purpose of this study is to evaluate safety and pharmacokinetics of single ascending IV doses of GMI-1359 in healthy adult subjects.
Detailed Description This is a randomized, double-blind, placebo-controlled, single ascending IV dose study conducted at one study center in the United States. Safety will be assessed throughout the study and serial blood samples and urine samples will be collected for the safety and pharmacokinetic assessment of GMI-1359.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: GMI-1359
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: GMI-1359
    Dose escalation
    Intervention: Drug: GMI-1359
  • Experimental: Placebo
    Dose escalation
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 1, 2019)
58
Original Estimated Enrollment  ICMJE
 (submitted: October 10, 2016)
20
Actual Study Completion Date  ICMJE November 2018
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy adult male or females, 19-60 years of age (inclusive).
  2. Medically healthy with no clinically significant screening results.
  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, and be willing and able to comply with the protocol.

Exclusion Criteria:

  1. Subject is mentally or legally incapacitated.
  2. 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 subjects by their participation in the study.
  3. Normal clinical laboratory values.
  4. Normal heart rate and blood pressure.
  5. Blood donation or significant blood loss within 56 days prior to dosing.
  6. Plasma donation within 7 days prior to dosing.
  7. Participation in another clinical trial within 28 days prior to dosing.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02931214
Other Study ID Numbers  ICMJE GMI-1359-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party GlycoMimetics Incorporated
Study Sponsor  ICMJE GlycoMimetics Incorporated
Collaborators  ICMJE Celerion
Investigators  ICMJE
Principal Investigator: Laura Sterling, MD Celerion
PRS Account GlycoMimetics Incorporated
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP