Mass Balance Recovery, Metabolite Profile and Metabolite Identification of 14C-AB1010 in Healthy Male Subjects

• Sponsor: AB Science (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05200169
• Collaborator: (none)
• Enrollment: 4
• Location: 1
• Arm: 1
• Actual Duration (Months): 1.1
• Patients Per Site Per Month: 3.8

Study Details

Study Description

Brief Summary

To assess the mass balance recovery after a single oral dose of 14C-AB1010

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: 14C-AB1010	Early Phase 1

Detailed Description

The objective is to characterize the distribution, metabolism and elimination of AB1010 in humans through the sampling of blood, urine, and faeces. This is accomplished through the administration of 14C-AB1010 oral solution with a therapeutic relevant dose of AB1010 as a single oral dose. There was no control group and no blinding as the objective was to assess the mass balance of masitinib after a single oral intake. There was only one group of healthy male volunteers.

Study Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: An open label, non-randomized, single-dose, single-period studyAn open label, non-randomized, single-dose, single-period study
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label, Non-Randomised, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of 14C-AB1010 in Healthy Male Subjects
• Actual Study Start Date: Jul 31, 2017
• Actual Primary Completion Date: Sep 1, 2017
• Actual Study Completion Date: Sep 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 14C-AB1010 Oral solution of 14C radiolabelled AB1010 (200 mg per subject)	Drug: 14C-AB1010; Oral solution of 14C radiolabelled AB1010 (200 mg per subject); Other Names: radiolabelled masitinib

Outcome Measures

Primary Outcome Measures

1. Radioactivity recovery [168 hours post-dose]

   Cumulative Amount of Total Radioactivity Excreted in Urine. No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. No formal statistical analysis were performed for this study due to the small number of subjects, for which statistical inference is not meaningful.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria Included:

• Healthy Male as determined by a physician, based on a medical evaluation including medical history, physical examination, clinical laboratory tests and 12-lead ECG. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the Sponsor Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.

• Male between 18 and 65 years old inclusive, at the time of signing the informed consent.

• Body mass index of 18.0 to 32.0 kg/m2, inclusive at screening

• Body weight between 60 and 90 kg

• Normal blood pressure and heart rate or, if abnormal, considered not clinically significant by the principal Investigator or sub-investigator.

• Neutrophils count should be within normal range or deemed as not clinically significant by the PI

• Must have regular bowel movements (ie, average stool production of ≥1 and ≤3 stools per day)

Exclusion Criteria Included:

• Any clinically significant cardio vascular diseases such as but not limited to the common reported below:

• History or presence or suspect of Acute Coronary Syndrome, Myocardial Infarction, Coronary Artery bypass graft surgery or stent procedure;

• History or presence or suspect of Angina Pectoris;

• History or presence or suspect, heart failure;

• Abnormal vital signs

• Clinically significant abnormal Blood Pressure according to investigator's opinion

• Abnormal resting ECG according investigator's opinion.

• Clinically significant, abnormal medical history, physical findings, ECG, or laboratory values at the screening visit that could interfere with the objectives of the study or the safety of the volunteer.

• A history of clinically significant acute illness (resolved within 4 weeks of screening), or history of significant cardiac arrhythmias or unexplained syncope or presence of cardiovascular, gastrointestinal, renal, hepatic, neurologic, haematologic, endocrine, oncologic, pulmonary, immunologic, dermatologic or psychiatric disease or any other condition which, in the opinion of the Principal Investigator (PI), would jeopardize the safety of the subject or impact the validity of the study results.

• Subject has an uncontrolled intercurrent illness (i.e., active infection) or fever (oral temperature > 38 degrees Celsius) at screening.

• Clinically significant history of or current seizure disorder or history of syncope, unexplained loss of consciousness or clinically significant history of Central Nervous System (CNS) disorders

• Failure to satisfy the investigator of fitness to participate for any other reason

Contacts and Locations

Locations

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

Sponsors and Collaborators

• AB Science

Investigators

• Principal Investigator: Nand Singh, MD, Quotient Clinical Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AB Science
• ClinicalTrials.gov Identifier: NCT05200169
• Other Study ID Numbers: AB17001; 2017-001948-34
• First Posted: Jan 20, 2022
• Last Update Posted: Jan 21, 2022
• Last Verified: Jan 1, 2022

• 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

Study Results

No Results Posted as of Jan 21, 2022