Healthy SubjectsPhase 1NCT03606447
A Study in Healthy Volunteers to Investigate How Much Test Medicine [14C]-Uproleselan is Taken up by the Body When Administered Directly Into the Vein (IV)
A Phase 1 study testing Uproleselan in people with Healthy Subjects, run by GlycoMimetics Incorporated at 1 site in United Kingdom.
Trial summary
The purpose of the study is to measure how the radiolabelled test medicine [14C]-Uproleselan (GMI-1271) is taken up, broken down and removed from the body when given intravenously (into a vein) in a group of 6 males. Read more about this study
- Who is it for?
- Ages 30 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Uproleselan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Aug 2018to 13 Sep 2018
- 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 30 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males
- Age 30 to 65 years of age
- Body mass index (BMI) of 18.0 to 35.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
- Must be willing and able to communicate and participate in the whole study
- Must have regular bowel movements (ie, average stool production of ≥1 and ≤3 stools per day)
- Must provide written informed consent
- Must adhere to the contraception requirements
Who cannot join
- Subjects who have received any IMP in a clinical research study within the previous 3 months
- Subjects who are study site employees, or immediate family members of a study site or sponsor employee
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption
- Current smoking or use of tobacco products or substitutes.
- Current users of e-cigarettes and nicotine replacements products
Show all 18Show fewer
- Radiation exposure
- Subjects who have completed 2 ADME studies in the last 12 months
- Clinically significant abnormal biochemistry, hematology or urinalysis
- Positive drugs of abuse test result
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
- Evidence of renal impairment at screening
- History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder
- Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
- Presence or history of clinically significant allergy requiring treatment
- Donation or loss of greater than 400 mL of blood within the previous 3 months
- Subjects who are taking, or have taken, any prescribed or over-the-counter drug
- Vaccination with any live vaccine within 4 weeks of study drug administration
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quotient Sciences Limited
Ruddington, Nottingham, NG11 6JS
About this study
Official title: An Open Label, Single-dose, Single-period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-Uproleselan Administered Via the Intravenous Route to Healthy Subjects (ADME Study of IV [14C]-Uproleselan in Healthy Subjects)
The purpose of the study is to measure how the radiolabelled test medicine [14C]-Uproleselan (GMI-1271) is taken up, broken down and removed from the body when given intravenously (into a vein) in a group of 6 males. 'Radiolabelled' means that the test medicine has a radioactive component which helps us to track where the drug is in the body. Blood urine and fecal samples will be collected at specific times throughout the study to measure amounts of the test medicine in the body.
- Conditions
- Healthy Subjects
- Being tested
- Uproleselan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UproleselanDrug
[14C]-Uproleselan
| Study group | Role | What they receive |
|---|---|---|
| Single IV administration of [14C]-Uproleselan | Experimental | Not described Receives: Drug: Uproleselan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mass Balance Recovery
Urine and feces will be collected at different time points and the radioactivity will be measured. The recovery will be expressed as percentage of radioactivity administered
Measured: up to 8 days
Tmax
The time from dosing at which Cmax was apparent
Measured: up to 8 days
Cmax
maximum observed concentration
Measured: up to 8 days
AUC(0-last)
area under the curve from 0 time to last measurable concentration
Measured: up to 8 days
AUC(0-inf)
area under the curve from 0 time extrapolated to infinity
Measured: up to 8 days
AUC%extrap
percentage of AUC(0-inf) extrapolated beyond last measured time point
Measured: up to 8 days
lambda-z
the apparent elimination rate constant
Measured: up to 8 days
T1/2
the apparent elimination half-life
Measured: up to 8 days
CI
clearance, the apparent volume cleared of parent drug per unit time after intravenous administration
Measured: up to 8 days
Vx
the apparent volume of distribution after intravenous administration
Measured: up to 8 days
MRT
mean residence time
Measured: up to 8 days
Ae(urine)
the amount of Uproleselan excreted in the urine expressed as a percentage of the administered dose
Measured: up to 8 days
%Ae(urine)
the amount of Uproleselan excreted in the urine expressed as a percentage of the administered dose
Measured: up to 8 days
CLr
renal clearance: the apparent volume of plasma cleared of Uproleselan per unit time via renal elimination, calculated as: CLr = Ae (urine) / AUC
Measured: up to 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start14 Aug 2018
- Primary completion13 Sep 2018
- Study completion13 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlycoMimetics Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Responsible party
- Sponsor
- Investigators
- Nand Singh, MD,DPM,MFPM, Principal investigator, Quotient Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03606447
- Sponsor's protocol ID
- GMI-1271-104
- Status last verified
- May 2019
- First submitted
- 23 Jul 2018
- Last updated
- 14 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single-dose, Single-period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-Uproleselan Administered Via the Intravenous Route to Healthy Subjects (ADME Study of IV [14C]-Uproleselan in Healthy Subjects)
- ClinicalTrials.gov ID
- NCT03606447
- Acronym / sponsor ID
- GMI-1271-104
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- GlycoMimetics IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Study start
- 14 Aug 2018 (actual)
- Primary completion
- 13 Sep 2018 (actual)
- Study completion
- 13 Sep 2018 (actual)
- First posted
- 30 Jul 2018 (actual)
- 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.
The purpose of the study is to measure how the radiolabelled test medicine [14C]-Uproleselan (GMI-1271) is taken up, broken down and removed from the body when given intravenously (into a vein) in a group of 6 males. 'Radiolabelled' means that the test medicine has a radioactive component which helps us to track where the drug is in the body. Blood urine and fecal samples will be collected at specific times throughout the study to measure amounts of the test medicine in the body.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single IV administration of [14C]-Uproleselan | Experimental | Drug: Uproleselan |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy males
- Age 30 to 65 years of age
- Body mass index (BMI) of 18.0 to 35.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
- Must be willing and able to communicate and participate in the whole study
- Must have regular bowel movements (ie, average stool production of ≥1 and ≤3 stools per day)
Key exclusion criteria (18 listed)
- Subjects who have received any IMP in a clinical research study within the previous 3 months
- Subjects who are study site employees, or immediate family members of a study site or sponsor employee
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption
- Current smoking or use of tobacco products or substitutes.
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 |
|---|---|---|
| Uproleselan[14C]-Uproleselan | Drug | Single IV administration of [14C]-Uproleselan |
Primary outcome
Mass Balance Recovery
Time frame: up to 8 days
Urine and feces will be collected at different time points and the radioactivity will be measured. The recovery will be expressed as percentage of radioactivity administered
Tmax
Time frame: up to 8 days
The time from dosing at which Cmax was apparent
Cmax
Time frame: up to 8 days
maximum observed concentration
AUC(0-last)
Time frame: up to 8 days
area under the curve from 0 time to last measurable concentration
AUC(0-inf)
Time frame: up to 8 days
area under the curve from 0 time extrapolated to infinity
AUC%extrap
Time frame: up to 8 days
percentage of AUC(0-inf) extrapolated beyond last measured time point
lambda-z
Time frame: up to 8 days
the apparent elimination rate constant
T1/2
Time frame: up to 8 days
the apparent elimination half-life
CI
Time frame: up to 8 days
clearance, the apparent volume cleared of parent drug per unit time after intravenous administration
Vx
Time frame: up to 8 days
the apparent volume of distribution after intravenous administration
MRT
Time frame: up to 8 days
mean residence time
Ae(urine)
Time frame: up to 8 days
the amount of Uproleselan excreted in the urine expressed as a percentage of the administered dose
%Ae(urine)
Time frame: up to 8 days
the amount of Uproleselan excreted in the urine expressed as a percentage of the administered dose
CLr
Time frame: up to 8 days
renal clearance: the apparent volume of plasma cleared of Uproleselan per unit time via renal elimination, calculated as: CLr = Ae (urine) / AUC
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 14 May 2019.
- Individual participant dataSharing planned: No
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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.
Nand Singh, MD,DPM,MFPM principal investigator
Quotient Sciences
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 Uproleselan in people with Healthy Subjects, run by GlycoMimetics Incorporated at 1 site in United Kingdom.
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 7 inclusion and 18 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 14 May 2019. 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 Kingdom. 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. 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?
Mass Balance Recovery (time frame: up to 8 days). The study lists 14 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 14 May 2019.