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)

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: Uproleselan

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham
    • Ruddington, Nottingham, United Kingdom, NG11 6JS
      • Quotient Sciences Limited

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single IV administration of [14C]-Uproleselan	Drug: Uproleselan; [14C]-Uproleselan

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: GlycoMimetics Incorporated
• Collaborators: Quotient Sciences
• Investigators: Principal Investigator: Nand Singh, MD,DPM,MFPM, Quotient Sciences

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2018
• Primary Completion (Actual): September 13, 2018
• Study Completion (Actual): September 13, 2018

Study Registration Dates

• First Submitted: July 23, 2018
• First Submitted That Met QC Criteria: July 23, 2018
• First Posted (Actual): July 30, 2018

Study Record Updates

• Last Update Posted (Actual): May 14, 2019
• Last Update Submitted That Met QC Criteria: May 13, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: GMI-1271-104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No