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:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-25 @ 4:30 AM
NCT ID:
NCT04037618
Eligibility Criteria:
Inclusion Criteria:
* Able to provide informed consent to participate in this study.
* Healthy and free from clinically significant illness or disease as determined by medical history, physical examination, laboratory and other tests at Screening.
* A body weight of ≥60 kg and a body mass index ranging from 18.0 to 35.0 kg/m2 at Screening.
* Subject must agree to minimize the risk of a female partner becoming pregnant from the dosing day until 3 months after the completion of the study. Acceptable methods of contraception for male volunteers include abstinence from sexual intercourse, a vasectomy no less than 6 months prior to dosing, barrier contraception or a medically accepted contraceptive method. For female partners of male volunteers, acceptable methods of contraception include intra-uterine device (which should be placed at least 1 month before the start of the study), tubal ligation (which took place at least 6 months prior to the start of the study), hormonal contraceptive since at least two months and diaphragm with spermicide. If the subject is a sperm donor, the subject must agree not to donate sperm during the study and until 90 days after the last intake of study drug.
* In the Investigator's opinion, subject is able to understand the nature of the study and any risks involved in participation, and willing to cooperate and comply with the protocol restrictions and requirements.
Exclusion Criteria:
* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance.
* History or current clinically significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders.
* History of any major surgery within the last 4 weeks before participation in this study or any bone fracture within the last 2 months.
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders.
* Chronic or relevant acute infections.
* History of allergy/ hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator.
* History of any bleeding disorder including prolonged or habitual bleeding, other hematologic disease or cerebral bleeding (e.g. after a car accident) or commotion cerebri.
* Intake of drugs with a long half-life (\>24 hours) within 1 month prior to study drug administration.
* Use of any kind of prescription medication from 14 days prior to the administration of the study drug.
* Use of any kind of over-the-counter products and/or natural health products (including food supplements, herbal supplements, etc.) from 7 days prior to the administration of the study drug.
* Participation in another trial with an investigational drug within 2 months prior to administration of the study drug or during the trial.
* The subject is a smoker or uses other nicotine-containing products.
* Alcohol abuse.
* History of drug abuse.
* Blood donation within 3 months prior to administration or during the trial.
* Any laboratory value outside the reference range, unless considered to lack clinical relevance.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT04037618
Study Brief:
Protocol Section:
NCT04037618