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)

GlycoMimetics

Status and phase

Completed

Phase 1

Conditions

Healthy Subjects

Treatments

Drug: Uproleselan

Study type

Interventional

Funder types

Industry

Identifiers

NCT03606447

GMI-1271-104

Details and patient eligibility

About

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.

Enrollment

5 patients

Sex

Male

Ages

30 to 65 years old

Volunteers

Accepts Healthy Volunteers

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