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 @ 9:14 PM
Ignite Modification Date:
2025-12-24 @ 9:14 PM
NCT ID:
NCT02448004
Eligibility Criteria:
Inclusion Criteria:
* Participants must agree to comply with contraceptive measures as mentioned in protocol
* Must be non-smokers for at least 3 months prior to screening
* Must have a Body Mass Index (BMI; weight in kilogram divided by the square of height in meters) of 18.0 to 30.0 kilogram/meter square, extremes included
* Must have signed an Informed consent form indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study before starting any screening activities
* Must be willing/able to adhere to the prohibitions and restrictions specified in the protocol and study procedures
* Must have a normal 12-lead ECG (based on the mean value of the triplicate parameters) at screening and on Day 1 predose including: 1). normal sinus rhythm (heart rate between 45 and 100 beats per minute \[bpm\], extremes included); 2). QT interval corrected for heart rate according to Fridericia (QTcF) interval less than or equal to (\<=) 450 milliseconds (ms); 3). QRS interval lower than 120 ms; 4). PR interval \<= 220 ms
Exclusion Criteria:
* Participants with a past history of heart arrhythmias (extrasystoli clinically significant in the opinion of the investigator, tachycardia at rest) or of risk factors for Torsade de Pointes syndrome
* Participants with more than one episode of constipation (less than 1 stool per 3 days) during the last 2 months, or more than one episode of diarrhea (3 or more stools per day) during the last 2 months
* Participants with a history of or a reason to believe the subject has a history of drug or alcohol abuse within the past 5 years
* Participants having a positive urine drug test at study screening or on Day -1. Urine will be tested for the presence of amphetamines, benzodiazepines, cocaine, cannabinoids, opioids, methadone and barbiturates
* Participants with documented human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection at study screening
* Participants with current hepatitis A infection (confirmed by hepatitis A antibody immunoglobulin M (\[IgM\]), or hepatitis B virus (HBV) infection (confirmed by hepatitis B surface antigen \[HbsAg\]), or hepatitis C virus (HCV) infection (confirmed by HCV antibody) at study screening
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02448004
Study Brief:
Protocol Section:
NCT02448004