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 @ 3:06 PM
Ignite Modification Date:
2025-12-24 @ 3:06 PM
NCT ID:
NCT02625259
Eligibility Criteria:
Inclusion Criteria:
1. Is aged 18 to 45 years inclusive, at the time of consent.
2. Is healthy adult male or female.
3. Weighs greater than or equal to (\>=) 45 kilogram (kg) (female) or \>=55 kg (male), and body mass index (BMI) between 18.0 and 30.0 kilogram per square meter (kg/m\^2), inclusive, at screening.
4. Suitable venous access for the study-required blood sampling, including PK sampling.
5. Has provided the voluntary written consent.
Exclusion Criteria:
1. Any clinically significant abnormality at screening or medical history of cardiac, hepatic, renal, respiratory, gastrointestinal (GI), endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
2. Manifestations of malabsorption due to prior GI surgery, GI disease, or for an unknown other reason that may alter the PK of TAK-117 or lansoprazole.
3. Creatinine clearance less than or equal to (\<=) 90 milliliter per minute (mL/min) based either on Cockroft-Gault estimate or based on a 12- or 24-hour urine collection during screening.
4. Known intolerance to TAK-117 or lansoprazole, or any of the excipients of either drug.
5. A positive test result for human immunodeficiency virus (HIV), hepatitis A antibody (HAVAb), hepatitis B surface antigen (HBsAg), hepatitis B core (HBc) antibody Anti-HBc (IgM), or hepatitis C antibody (HCVAb) tests at screening, or serological reactions for syphilis during screening.
6. Has Lactose intolerance (only for Part 2).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02625259
Study Brief:
Protocol Section:
NCT02625259