Clinical trial NCT03606447: 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)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: GlycoMimetics Incorporated
Sponsor class: INDUSTRY
Collaborators: name: Quotient Sciences
First posted: 2018-07-30
Enrollment: 5
Sex: MALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Mass Balance Recovery
timeFrame: up to 8 days
measure: Tmax
timeFrame: up to 8 days
measure: Cmax
timeFrame: up to 8 days
measure: AUC(0-last)
timeFrame: up to 8 days
measure: AUC(0-inf)
timeFrame: up to 8 days
measure: AUC%extrap
timeFrame: up to 8 days
measure: lambda-z
timeFrame: up to 8 days
measure: T1/2
timeFrame: up to 8 days
measure: CI
timeFrame: up to 8 days
measure: Vx
timeFrame: up to 8 days
measure: MRT
timeFrame: up to 8 days
measure: Ae(urine)
timeFrame: up to 8 days
measure: %Ae(urine)
timeFrame: up to 8 days
measure: CLr
timeFrame: up to 8 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ruddington
country: United Kingdom
facility: Quotient Sciences Limited
state: Nottingham
Study officials:
affiliation: Quotient Sciences
name: Nand Singh, MD,DPM,MFPM
role: PRINCIPAL_INVESTIGATOR
References: