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)

NCT ID: NCT03606447

Last Updated: 2019-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-14
• Study Completion Date: 2018-09-13

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.

Conditions

Healthy Subjects

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Single IV administration of [14C]-Uproleselan

Group Type: EXPERIMENTAL

Uproleselan

Intervention Type: DRUG

\[14C\]-Uproleselan

Interventions

Uproleselan

\[14C\]-Uproleselan

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Quotient Sciences

INDUSTRY

Sponsor Role: collaborator

GlycoMimetics Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nand Singh, MD,DPM,MFPM

Role: PRINCIPAL_INVESTIGATOR

Quotient Sciences

Locations

Quotient Sciences Limited

Ruddington, Nottingham, United Kingdom

Countries

United Kingdom

Other Identifiers

GMI-1271-104

Identifier Type: -

Identifier Source: org_study_id