Phase 3 Open-Label Crossover Pharamacodynamic study to Evaluate the Acid-inhibitory Effect of TAK-438 20 mg with Esomeprazole 20 mg or Rabeprazole Sodium 10 mg in Healthy Adult Male Subjects
- Conditions
- Healthy Japanese adult male
- Registration Number
- JPRN-jRCT2080222361
- Lead Sponsor
- TAKEDA PHARMACEUTICAL COMPANY LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Male
- Target Recruitment
- 40
1. Is a healthy Japanese adult male volunteer
2. Is aged 20 to 45 years, inclusive, at the time of informed consent.
3. Has been confirmed at CYP2C19 genotyping as an Extensive Metabolizer [EM (*1/*1,*1/*2,*1/*3)] .
4. Capable of understanding and complying with the protocol requirements.
5. The participant signs and dates a written informed consent form prior to the initiation of any study procedures.
6. Weighs 50 kg or more and has BMI of 18.5 or more and less than 25.0 kg/m2 at Screening or admission (Day -3).
7. Is H. pylori-negative at Screening.
1. Has undergone resection of the upper gastrointestinal tract or vagotomy.
2. Was determined to have hypoacidity or anacidity
3. Has a present or past history of acid-related disease (reflux esophagitis, gastric ulcer, duodenal ulcer, non-erosive gastroesophageal reflux, Barrett's esophagus, Zollinger-Ellison syndrome, etc.)
4. Has undergone eradication of H. pylori within 6 months prior to the start of the study drug administration.
5. Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormalities which may impact the ability of the subject to participate or potentially confound the study results.
6. Has a known hypersensitivities or allergies to drugs or food.
7. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 5 years prior to the start of the study drug administration.
8. Has poor peripheral venous access.
9. Had 200 mL or more of whole blood drawn within 4 weeks (28 days) prior to the start of the study drug administration or 400 mL or more of whole blood drawn within 12 weeks (84 days) prior to the start of the study drug administration.
10. Had a total volume of 800 mL or more of whole blood drawn within 52 weeks (364 days) prior to the start of the study drug administration.
11. Has undergone blood component draw within 2 weeks (14 days) prior to the start of the study drug administration.
12. Requires treatment with any of the excluded medications specified in the study or requires nutrition with any vitamin supplements or foods prohibited in the study.
13. Has received study medication within 16 weeks (112 days) prior to the start of the study drug administration.
14. Has received TAK-438 in the past.
15. Has a history of cancer.
16. Has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody/antigen or serological reactions for syphilis at Screening.
17. Has a Screening or admission (Day -3) abnormal clinically significant ECG.
18. Has abnormal Screening or admission (Day -3) laboratory values that suggest a clinically significant underlying disease or subject with the following lab abnormalities: ALT or AST > twice the upper limited of the normal range.
19. Is an immediate family member, study site employee, or in a dependent relationship with a study site employee who is involved in the conduct of this study (e.g., spouse, parent, child, sibling) or may consent under duress.
20. Participant who, in the opinion of the investigator or sub-investigator, is unlikely to comply with the protocol or is unsuitable for any other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Intragastric pH time course over 24 hours<br>Primary timeframe Baseline (Day -2 - Day -1), administration period (Day 1 - Day 2 and Day 7 - Day 8)<br>Intragastric pH will be measured continuously for 24 hours by pH meter.
- Secondary Outcome Measures
Name Time Method Frequency of adverse events, Change of vital signs, ECG findings, Number of participatns with markedly abnormal laboratory values<br>Secondary timeframe 31 days<br>Adverse events<br>The frequency of adverse events by type, seriousness, time to onset. Adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug to the last dose of study drug.<br>vital signs<br>Vital signs will include body temperature (oral or tympanic measurement), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (bpm).<br>clinical laboratory results<br>For clinical laboratory results, summary statistics will be calculated for observed values at baseline and each evaluation time point and for change from baseline for each study medication.