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)

• Sponsor: GlycoMimetics Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03606447
• Collaborator: Quotient Sciences (Industry)
• Enrollment: 5
• Location: 1
• Arm: 1
• Actual Duration (Days): 30
• Patients Per Site Per Month: 5.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects	Drug: Uproleselan	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• 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)
• Actual Study Start Date: Aug 14, 2018
• Actual Primary Completion Date: Sep 13, 2018
• Actual Study Completion Date: Sep 13, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Mass Balance Recovery [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 [up to 8 days]

   The time from dosing at which Cmax was apparent

3. Cmax [up to 8 days]

   maximum observed concentration

4. AUC(0-last) [up to 8 days]

   area under the curve from 0 time to last measurable concentration

5. AUC(0-inf) [up to 8 days]

   area under the curve from 0 time extrapolated to infinity

6. AUC%extrap [up to 8 days]

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

7. lambda-z [up to 8 days]

   the apparent elimination rate constant

8. T1/2 [up to 8 days]

   the apparent elimination half-life

9. CI [up to 8 days]

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

10. Vx [up to 8 days]

    the apparent volume of distribution after intravenous administration

11. MRT [up to 8 days]

    mean residence time

12. Ae(urine) [up to 8 days]

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

13. %Ae(urine) [up to 8 days]

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

14. CLr [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 65 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Quotient Sciences Limited	Ruddington	Nottingham	United Kingdom	NG11 6JS

Sponsors and Collaborators

• GlycoMimetics Incorporated
• Quotient Sciences

Investigators

• Principal Investigator: Nand Singh, MD,DPM,MFPM, Quotient Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GlycoMimetics Incorporated
• ClinicalTrials.gov Identifier: NCT03606447
• Other Study ID Numbers: GMI-1271-104
• First Posted: Jul 30, 2018
• Last Update Posted: May 14, 2019
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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

Study Results

No Results Posted as of May 14, 2019