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)

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: Uproleselan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single IV administration of [14C]-Uproleselan<br> | Drug: Uproleselan<br>* [14C]-Uproleselan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | up to 8 days | 
| Tmax | The time from dosing at which Cmax was apparent | up to 8 days | 
| Cmax | maximum observed concentration | up to 8 days | 
| AUC(0-last) | area under the curve from 0 time to last measurable concentration | up to 8 days | 
| AUC(0-inf) | area under the curve from 0 time extrapolated to infinity | up to 8 days | 
| AUC%extrap | percentage of AUC(0-inf) extrapolated beyond last measured time point | up to 8 days | 
| lambda-z | the apparent elimination rate constant | up to 8 days | 
| T1/2 | the apparent elimination half-life | up to 8 days | 
| CI | clearance, the apparent volume cleared of parent drug per unit time after intravenous administration | up to 8 days | 
| Vx | the apparent volume of distribution after intravenous administration | up to 8 days | 
| MRT | mean residence time | up to 8 days | 
| Ae(urine) | the amount of Uproleselan excreted in the urine expressed as a percentage of the administered dose | up to 8 days | 
| %Ae(urine) | the amount of Uproleselan excreted in the urine expressed as a percentage of the administered dose | 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 | up to 8 days |