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 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT02972905
Eligibility Criteria:
Inclusion Criteria
* Participant must be 20 to 64 years of age inclusive, at the time of signing the informed consent.
* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG. A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the investigator in consultation with the Medical Monitor if required agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
* Normal spirometry (forced expiratory volume in 1 second \>=80% of predicted) at Screening.
* Body weight \>=50 kilograms (kg) and body mass index (BMI) within the range 18.5 to 24.9 kg/square meter (m\^2) (inclusive).
* Japanese Male: A male participant must agree to use contraception of this protocol during the treatment period and until follow up visit.
* Capable of giving signed informed consent as described in restrictions listed in the informed consent form (ICF).
Exclusion Criteria
* History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatment; or interfering with the interpretation of data
* Abnormal blood pressure as determined by the investigator
* ALT \>1.5x upper limit of normal (ULN)
* Bilirubin \>1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%)
* Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
* QTcF \>450 milliseconds (msec).
* Past or intended use of over-the-counter or prescription medication including herbal medications within 14 days prior to dosing.
* History of donation of blood or blood products \>=400 milliliters (mL) within 3 months or \>=200 mL within 1 month prior to screening
* Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day
* Current enrollment or past participation within the last 30 days before signing of consent in this clinical study involving an investigational study treatment or any other type of medical research
* The subject is positive Serological test for syphilis (rapid plasma reagin and Treponema pallidum), Human immunodeficiency virus (HIV) Antigen/Antibody, Hepatitis B surface antigen (HbsAg), Hepatitis C virus (HCV) antibody, or Human T-cell lymphotropic virus type 1 (HTLV-1) antibody at screening.
* Positive pre-study drug screen
* Regular use of known drugs of abuse
* Regular alcohol consumption within 6 months prior to the study defined as: for an average weekly intake of \>14 units for males. One unit is equivalent to 350 ml of beer, 150 ml of wine or 45 ml of 80 proof distilled spirits
* Smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening
* Sensitivity to any of the study treatments, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
64 Years
Study:
NCT02972905
Study Brief:
Protocol Section:
NCT02972905