Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2025-12-24 @ 5:45 PM
NCT ID:
NCT05027568
Eligibility Criteria:
Inclusion Criteria:
* Healthy male subjects between 18 and 50 years of age (inclusive) at the screening visit
* Body mass index between 18.0 and 30.0 kg/m2 (inclusive) at the screening visit
* In good health as determined by medical history, physical examination, ECG, serum/urine, clinical chemistry, haematology, and serology tests
* Able to provide written, informed consent prior to initiation of any trial-related procedures, and able, in the opinion of the Principal Investigator, to comply with all the requirements of the trial
* Male subjects who are surgically sterile (i.e., have undergone bilateral orchidectomy); and male subjects who agree to remain abstinent or to practice double-barrier forms of birth control and refrain from sperm donation from trial screening through 90 days from the last dose of IMP
Exclusion Criteria:
* Clinically significant abnormality in past medical history, or at the screening physical examination, that in the Investigator's or Sponsor's opinion may place the subject at risk or interfere with outcome variables including absorption, distribution, metabolism, and excretion of IMP
* History of drug and/or alcohol abuse within 2 years prior to the screening visit
* History of or current hepatitis or acquired immunodeficiency syndrome or carriers of HBsAg, anti-HCV, and/or HIV antibodies
* History of any significant drug allergy
* Positive alcohol breath test and/or urine drug screen for substance of abuse at the screening visit or upon check-in to the clinical trial site
* History of having taken an investigational drug within 30 days preceding trial entry
* History of significant bleeding or haemorrhagic tendencies
* Donation of blood or plasma within 30 days prior to dosing
* Use of prescription medication, over-the-counter medication, herbal medication, or vitamin supplements within 14 days prior to dosing and antibiotics within 30 days prior to dosing. The Sponsor may allow exceptions only if the medication's administration is deemed unlikely to impact the PK result
* Exposure to any substances known to stimulate hepatic microsomal enzymes within 30 days prior to screening (e.g., occupational exposure to pesticides, organic solvents)
* Supine blood pressure, after resting for ≥3 minutes, higher than 140/90 mmHg or lower than 100/50 mmHg. The Sponsor may allow exceptions if they are not deemed clinically significant
* Supine pulse rate, after resting for ≥3 minutes, outside the range of 50 to 90 bpm. The Sponsor may allow exceptions if they are not deemed clinically significant
* History of serious mental disorders that, in the opinion of the Investigator, would exclude the subject from participating in this trial
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT05027568
Study Brief:
Protocol Section:
NCT05027568