TAK-438 Bismuth Drug Interaction Study
Condition: Helicobacter Pylori
Intervention: Clarithromycin; Amoxicillin; Tripotassium bismuth dicitrate; Lansoprazole; TAK-438
Intervention description: Clarithromycin tablets; Amoxicillin capsules; Tripotassium bismuth dicitrate tablets; Lansoprazole capsules; TAK-438 tablets
Intervention MeSH terms: Amoxicillin; Clarithromycin; Lansoprazole; Dexlansoprazole; Bismuth
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 19 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Drug Therapy

Summary:

      To evaluate the safety, tolerability, and pharmacokinetics (PK) of quadruple therapy with
      bismuth, clarithromycin, amoxicillin, and TAK-438 versus quadruple therapy with bismuth,
      clarithromycin, amoxicillin, and lansoprazole.
    

Eligibility criteria:

        Inclusion Criteria:

          1. HP positive participants.

          2. Has body mass index between greater than (>) 18 and less than equal to (<=) 30
             kilogram per square meter (kg/m^2) and weighs greater than equal to (>=) 50 kilogram
             (kg).

          3. Is willing to abstain from strenuous exercise from 72 hours before first dose (Day 1)
             until the Follow-up call on Day 17.

        Exclusion Criteria:

          1. Has a positive urine drug result for drugs of abuse at Screening or Check-in (Day -1).

          2. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol
             abuse (defined as regular consumption of 21 units or more units per week) at any time
             prior to the Screening Visit or is unwilling to agree to abstain from alcohol and
             drugs throughout the study (up to Day 17).

          3. Has history of gastroesophageal reflux disease (GERD), symptomatic GERD, erosive
             esophagitis, duodenal ulcer, gastric ulcer, Barrett's esophagus, or Zollinger-Ellison
             syndrome.

          4. Has undergone therapeutic upper gastrointestinal endoscopic therapy (example,
             endoscopic hemostasis or excision including biopsy) within 30 days prior to Screening.

          5. Has undergone major surgical procedures within the past 1 month or are scheduled to
             undergo surgical procedures that may affect gastric acid secretion (example, abdominal
             surgery, vagotomy, or craniotomy).

          6. Has a history of cancer, except basal cell carcinoma or Stage 1 squamous cell
             carcinoma of the skin that has been in remission for at least 5 years prior to Day 1.

          7. Has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus
             (HCV) antibody, human immunodeficiency virus (HIV) antibody/antigen at Screening.

          8. Has used nicotine-containing products (including but not limited to cigarettes, pipes,
             cigars, chewing tobacco, nicotine patch or nicotine gum) within 6 weeks prior to
             Check-in. Cotinine test is positive at Screening or Check-in.

          9. Has poor peripheral venous access. Has donated or lost 450 milliliter (mL) or more of
             his blood volume (including plasmapheresis), or had a transfusion of any blood product
             within 90 days prior to Day 1.

         10. Has abnormal Screening or Check-in laboratory values that suggest a clinically
             significant underlying disease or subject with the following laboratory abnormalities:
             alanine aminotransferase (ALT), aspartate aminotransferase (AST) or total bilirubin >
             the upper limit of normal (ULN).

         11. Has reduced renal function assessed by having an estimated glomerular filtration rate
             <90 milliliter per min per 1.73 square meter (mL/min/1.73 m^2) (as estimated by
             Chronic Kidney Disease-Epidemology Collaboration) at Screening or Check-in.