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Completed

NCT Number: 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)

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.

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Key information

Conditions

Healthy Subjects

Age range

30 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Sciences Limited

Ruddington, Nottingham, NG11 6JS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Uproleselan

Drug

[14C]-Uproleselan

Primary outcomes

  1. Mass Balance Recovery

    Time frame: up to 8 days

    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

  2. Tmax

    Time frame: up to 8 days

    The time from dosing at which Cmax was apparent

  3. Cmax

    Time frame: up to 8 days

    maximum observed concentration

  4. AUC(0-last)

    Time frame: up to 8 days

    area under the curve from 0 time to last measurable concentration

  5. AUC(0-inf)

    Time frame: up to 8 days

    area under the curve from 0 time extrapolated to infinity

  6. AUC%extrap

    Time frame: up to 8 days

    percentage of AUC(0-inf) extrapolated beyond last measured time point

  7. lambda-z

    Time frame: up to 8 days

    the apparent elimination rate constant

  8. T1/2

    Time frame: up to 8 days

    the apparent elimination half-life

  9. CI

    Time frame: up to 8 days

    clearance, the apparent volume cleared of parent drug per unit time after intravenous administration

  10. Vx

    Time frame: up to 8 days

    the apparent volume of distribution after intravenous administration

  11. MRT

    Time frame: up to 8 days

    mean residence time

  12. Ae(urine)

    Time frame: up to 8 days

    the amount of Uproleselan excreted in the urine expressed as a percentage of the administered dose

  13. %Ae(urine)

    Time frame: up to 8 days

    the amount of Uproleselan excreted in the urine expressed as a percentage of the administered dose

  14. CLr

    Time frame: up to 8 days

    renal clearance: the apparent volume of plasma cleared of Uproleselan per unit time via renal elimination, calculated as: CLr = Ae (urine) / AUC

Sponsors and collaborators

Lead sponsor

GlycoMimetics Incorporated

Industry

Collaborators

  • Quotient Sciences

Registry information

Official study 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)

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 30, 2018
Registry last updated
May 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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