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 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT03951402
Eligibility Criteria:
Inclusion Criteria:
* Male or female Caucasian participants aged 45-65 years;
* Body mass index (BMI) between 19 and 27 kilograms/square meter inclusive;
* Participants must be in good health as determined by medical history, physical examination, 12-lead electrocardiogram , vital signs, and clinical laboratory parameters (serum/urine biochemistry, serology and haematology). Electrocardiogram (ECG) parameters and vitals signs must be in the ranges given in exclusion criteria 3-8 and 11-14, respectively) Minor deviations of laboratory values from the normal range may be accepted (except potassium and magnesium), if judged by the investigator to have no clinical relevance and if not considered to interfere with the study objectives.
* Negative human immunodeficiency virus (HIV) 1/2 -antibodies, hepatitis B surface (HBs)-antigen, hepatitis B core (HBc)-antibodies and hepatitis C virus (HCV)-antibodies at the prestudy medical examination;
* Negative blood beta-human chorionic gonadotropine (HCG)-test for women of child bearing potential;
* Participants giving written consent to participate within this study;
* Participants giving written consent for blood sampling to be genotyped for genes responsible for long QT syndrome (KCNQ1, human ether-a-go-go-related gene (HERG), SCN5A, KCNE1, KCNE2, KCNJ2).
Exclusion Criteria:
* Regular use of any medication within four weeks prior to commencement of the study (self-medication or prescription except for hormonal contraception and HRT);
* Smoker more than 5 cigarettes per day;
* No regular sinus rhythm;
* ECG interval: QRS complex above 100 millisecond;
* ECG interval: PQ above 200 milliseconds;
* ECG interval: RR above 1333 milliseconds;
* QT/QTc intervals above 450 milliseconds;
* Known family history of sudden cardiac death and arrhythmias;
* Diseases and functional disorders of the gastrointestinal tract, liver, cardiovascular system or kidneys;
* Malignancy;
* History of orthostatic hypotension;
* Resting pulse rate below 45 beats/min or above 90 beats per minute;
* Systolic blood pressure above 160 mmHg or below 100 mmHg;
* Diastolic blood pressure above 95 mmHg or below 50 mmHg;
* History of drug allergy;
* Bronchial asthma;
* Participation in another clinical trial within the last three months before starting this study (exception: characterisation of metaboliser status);
* Blood donation (more than 100 milliliters) in the last three months before the start of the study;
* History or evidence of alcohol or drug abuse;
* Positive drug abuse screening test;
* Extremely unbalanced diet (in the opinion of the investigator);
* Excessive consumption of food or beverages containing caffeine (more than 1000 milliliters of coffee per day or other equivalent amounts of caffeine);
* Known or suspected of not being able to comply with the study protocol;
* Not able to communicate meaningfully with the investigator and staff;
* Neurotic personality, psychiatric illness, or suicide risk;
* History of seizures;
* Known hypersensitivity to opioids or quinolones;
* Pregnancy (for female participants);
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
65 Years
Study:
NCT03951402
Study Brief:
Protocol Section:
NCT03951402