Healthy VolunteersPhase 1NCT02271113
Phase I Study to Assess Safety and Pharmacokinetics of GMI-1271 in Healthy Adult Subjects
A Phase 1 study testing GMI-1271 and Enoxaparin Sodium (Lovenox®) in people with Healthy Volunteers, run by GlycoMimetics Incorporated at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- GMI-1271 and Enoxaparin Sodium (Lovenox®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Mar 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo Controlled, Phase1 Study to Assess the Safety and Pharmacokinetics of GMI-1271 in Healthy Adult Subjects
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.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- GMI-1271, Placebo, Enoxaparin Sodium (Lovenox®)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GMI-1271Drug
PlaceboDrug
Enoxaparin Sodium (Lovenox®)Drug
| Study group | Role | What they receive |
|---|---|---|
| GMI-1271 | Experimental | IV GMI-1271 Receives: Drug: GMI-1271 |
| Placebo | Placebo comparator | IV Placebo Receives: Drug: Placebo |
| Enoxaparin Sodium (Lovenox®) | Active comparator | SC Lovenox® Receives: Drug: Enoxaparin Sodium (Lovenox®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events as a measure of safety and tolerability
Adverse Event data review
Measured: 14-19 days
Type of adverse events as a measure of safety and tolerability
Adverse Event data review
Measured: 14-19 days
Severity of adverse events as a measure of safety and tolerability
Adverse Event data review
Measured: 14-19 days
Review of lab results as a measure of Pharmacokinetics
Cmax (mg/mL)
Measured: 3-5 days
Review of lab results as a measure of Pharmacokinetics
AUC (mg/mL)
Measured: 3-5 days
Secondary outcomes (1)
Incidence of bleeding
Adverse Event data review
Measured: 14-19 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlycoMimetics Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Michigan
- Responsible party
- Sponsor
- Investigators
- Suman Sood, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02271113
- Sponsor's protocol ID
- GMI-1271-102
- Status last verified
- Feb 2018
- First submitted
- 8 Oct 2014
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo Controlled, Phase1 Study to Assess the Safety and Pharmacokinetics of GMI-1271 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02271113
- Acronym / sponsor ID
- GMI-1271-102
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- GlycoMimetics IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- University of Michigan
- Study start
- Oct 2014 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 22 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GMI-1271 | Experimental | Drug: GMI-1271IV GMI-1271 |
| Placebo | Placebo comparator | Drug: PlaceboIV Placebo |
| Enoxaparin Sodium (Lovenox®) | Active comparator | Drug: Enoxaparin Sodium (Lovenox®)SC Lovenox® |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GMI-1271 | Drug | GMI-1271 |
| Placebo | Drug | Placebo |
| Enoxaparin Sodium (Lovenox®) | Drug | Enoxaparin Sodium (Lovenox®) |
Primary outcome
Number of adverse events as a measure of safety and tolerability
Time frame: 14-19 days
Adverse Event data review
Type of adverse events as a measure of safety and tolerability
Time frame: 14-19 days
Adverse Event data review
Severity of adverse events as a measure of safety and tolerability
Time frame: 14-19 days
Adverse Event data review
Review of lab results as a measure of Pharmacokinetics
Time frame: 3-5 days
Cmax (mg/mL)
Review of lab results as a measure of Pharmacokinetics
Time frame: 3-5 days
AUC (mg/mL)
1 secondary outcome
Incidence of bleeding
Time frame: 14-19 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2018.
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suman Sood, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GMI-1271 and Enoxaparin Sodium (Lovenox®) in people with Healthy Volunteers, run by GlycoMimetics Incorporated at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events as a measure of safety and tolerability (time frame: 14-19 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2018.