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)
1 other identifier
interventional
5
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2018
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2018
CompletedFirst Posted
Study publicly available on registry
July 30, 2018
CompletedStudy Start
First participant enrolled
August 14, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 13, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 13, 2018
CompletedMay 14, 2019
May 1, 2019
1 month
July 23, 2018
May 13, 2019
Conditions
Outcome Measures
Primary Outcomes (14)
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
Study Arms (1)
Single IV administration of [14C]-Uproleselan
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlycoMimetics Incorporatedlead
- Quotient Sciencescollaborator
Study Sites (1)
Quotient Sciences Limited
Ruddington, Nottingham, NG11 6JS, United Kingdom
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Nand Singh, MD,DPM,MFPM
Quotient Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2018
First Posted
July 30, 2018
Study Start
August 14, 2018
Primary Completion
September 13, 2018
Study Completion
September 13, 2018
Last Updated
May 14, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share