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)

Healthy Subjects Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03606447
• Other study ID #: GMI-1271-104
• Status: Completed
• Phase: Phase 1
• Start date: August 14, 2018
• Est. completion date: September 13, 2018

Study information

• Verified date: May 2019
• Source: GlycoMimetics Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: September 13, 2018
• Est. primary completion date: September 13, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• Uproleselan
[14C]-Uproleselan

Locations

Country	Name	City	State
United Kingdom	Quotient Sciences Limited	Ruddington	Nottingham

Sponsors (2)

Lead Sponsor	Collaborator
GlycoMimetics Incorporated	Quotient Sciences

Country where clinical trial is conducted

United Kingdom, 

Outcome

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