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

NCT05200169 | Completed Early Phase 1

• 2 other identifiers: AB170012017-001948-34
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Radioactivity recovery

  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.

  168 hours post-dose

Study Arms (1)

14C-AB1010

EXPERIMENTAL

Oral solution of 14C radiolabelled AB1010 (200 mg per subject)

Drug: 14C-AB1010

Interventions

14C-AB1010 DRUG

Oral solution of 14C radiolabelled AB1010 (200 mg per subject)

Also known as: radiolabelled masitinib

14C-AB1010

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• AB Science: lead

Study Sites (1)

Quotient Sciences

Nottingham, NG11 6JS, United Kingdom

Location

Study Officials

• Nand Singh, MD

  Quotient Clinical Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: An open label, non-randomized, single-dose, single-period study

Study Record Dates

• First Submitted: December 27, 2021
• First Posted: January 20, 2022
• Study Start: July 31, 2017
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: January 21, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)