- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05200169
Mass Balance Recovery, Metabolite Profile and Metabolite Identification of 14C-AB1010 in Healthy Male Subjects
January 20, 2022 updated by: AB Science
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
To assess the mass balance recovery after a single oral dose of 14C-AB1010
Study Overview
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 Type
Interventional
Enrollment (Actual)
4
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Nottingham, United Kingdom, NG11 6JS
- Quotient Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 14C-AB1010
Oral solution of 14C radiolabelled AB1010 (200 mg per subject)
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Oral solution of 14C radiolabelled AB1010 (200 mg per subject)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radioactivity recovery
Time Frame: 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.
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168 hours post-dose
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nand Singh, MD, Quotient Clinical LTD
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 31, 2017
Primary Completion (Actual)
September 1, 2017
Study Completion (Actual)
September 1, 2017
Study Registration Dates
First Submitted
December 27, 2021
First Submitted That Met QC Criteria
January 7, 2022
First Posted (Actual)
January 20, 2022
Study Record Updates
Last Update Posted (Actual)
January 21, 2022
Last Update Submitted That Met QC Criteria
January 20, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- AB17001
- 2017-001948-34 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Masitinib is under clinical investigation and has not yet been approved in any sought-after indication by any health authority worldwide.
As such, there is no plan for data-sharing at this point in time.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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