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 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT03430232
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent prior to any study-mandated procedure
* Healthy male subjects, 18 to 45 years of age, inclusive at screening.
* Body mass index (BMI) between 18 and 30 kg/m2, inclusive at screening, and with a minimum weight of 50 kg.
* All males must practice effective contraception during the study and be willing and able to continue contraception for at least 90 days after their last dose of study treatment.
* Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions.
Exclusion Criteria:
* Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator
* Subject with clinically significant abnormalities in blood pressure, heart rate, ECG recording and laboratory parameters
* Abnormal renal function (eGFR (MDRD) \< 60 mL/min/1.73m2).
* Previous history of seizures or epilepsy.
* Acute disease state (e.g. nausea, vomiting, fever, or diarrhea) within 7 days before the first study day.
* Positive Hepatitis B surface antigen (HBsAg), Hepatitis B antibodies, Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab)
* Use of any medications (prescription or over-the-counter \[OTC\]), within 14 days of study drug administration, or less than 5 half-lives (whichever is longer).
* Use of any vitamin, mineral, herbal, and dietary supplements within 7 days of study drug administration, or less than 5 half-lives (whichever is longer).
* Participation in an investigational drug or device study within 3 months prior to first dosing.
* History of abuse of addictive substances or current use of substances (alcohol, illegal substances)
* Positive test for drugs of abuse or alcohol breath test at screening or pre-dose.
* Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, or multiple drug allergies (non-active hay fever is acceptable).
* Loss or donation of blood over 500 mL within three months prior to screening
* Any current, clinically significant, known medical condition in particular any existing conditions that would affect sensitivity to cold or pain
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03430232
Study Brief:
Protocol Section:
NCT03430232