Healthy Subjects
Conditions
Brief 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. '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.
Interventions
DRUGUproleselan
\[14C\]-Uproleselan
Sponsors
Quotient Sciences
GlycoMimetics Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
30 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mass Balance Recovery | 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 | up to 8 days | The time from dosing at which Cmax was apparent |
| Cmax | up to 8 days | maximum observed concentration |
| AUC(0-last) | up to 8 days | area under the curve from 0 time to last measurable concentration |
| AUC(0-inf) | up to 8 days | area under the curve from 0 time extrapolated to infinity |
| AUC%extrap | up to 8 days | percentage of AUC(0-inf) extrapolated beyond last measured time point |
| lambda-z | up to 8 days | the apparent elimination rate constant |
| T1/2 | up to 8 days | the apparent elimination half-life |
| CI | up to 8 days | clearance, the apparent volume cleared of parent drug per unit time after intravenous administration |
| Vx | up to 8 days | the apparent volume of distribution after intravenous administration |
| MRT | up to 8 days | mean residence time |
| Ae(urine) | up to 8 days | the amount of Uproleselan excreted in the urine expressed as a percentage of the administered dose |
| %Ae(urine) | up to 8 days | the amount of Uproleselan excreted in the urine expressed as a percentage of the administered dose |
| CLr | 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 |
Countries
United Kingdom
Outcome results
None listed