Food Effect Study with Final Formulation (20 mg) of TAK-438
- Conditions
- Healthy Volunteer
- Registration Number
- JPRN-jRCT2080223047
- Lead Sponsor
- TAKEDA PHARMACEUTICAL COMPANY LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Male
- Target Recruitment
- 12
1. In the opinion of the investigator or sub-investigators, the subject was capable of understanding and complying with the protocol requirements.
2. The subject had signed and dated a written, informed consent form prior to the initiation of any study procedures.
3. The subject was a healthy Japanese adult male.
4. The subject was aged 20 to 35 years, inclusive, at the time of informed consent.
5. The subject weighed at least 50.0 kg and had a body mass index (BMI) between 18.5 kg/m^2 and 24.9 kg/m^2, inclusive, at screening.
1. The subject had received any investigational compound (including those in post-marketing studies) within 16 weeks (112 days) prior to screening.
2. The subject had received TAK-438 in a previous clinical study.
3. The subject was a study site employee or his/her family member, or in a dependent relationship with a study site employee who was involved in the conduct of the study (e.g., spouse, parent, child, sibling) or who may consent under duress.
4. The subject had uncontrolled, clinically significant neurological, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality which may impact the ability of the subject to participate or potentially confound the study results.
5. The subject had a history of hypersensitivity or allergies to any component1 of the formulation of TAK-438.
6. Subject had a positive urine drug test result at screening.
7. The subject had a history or complication of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to screening or was unwilling to agree to abstain from alcohol and drugs throughout the study.
8. The subject had taken any excluded medications, vitamin supplements, or food product.
9. Subject had evidence of current cardiovascular, central nervous system, hepatic, hematopoietic diseases, renal dysfunction, metabolic or endocrine dysfunction, serious allergy, asthma, hypoxemia, hypertension, seizures, or allergic skin rash. Any finding in the subject's medical history, physical examinations, or safety clinical laboratory tests suggesting a disease for which TAK-438 or a similar drug that is a gastric acid secretion inhibitor (i.e., PPIs) would be contraindicated, or which may interfere with the conduct of the study. This included, but was not limited to, seizure disorders and cardiac arrhythmias.
10. Subject had a history or complication of gastrointestinal disease that may influence the absorption of drugs (i.e., malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent heartburn, or a history of surgical intervention [e.g., cholecystectomy]) within 6 months prior to screening.
11. Subject had a history of cancer within 5 years prior to the first dose of study medication.
12. Subject had a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody/antigen, or had serological reactions for syphilis at screening.
13. Subject used nicotine-containing products (i.e., cigarettes, pipe tobaccos, cigars, chewing tobaccos, nicotine patches or nicotine-containing gums) within 28 days prior to check-in (Day -1).
14. The subject had poor peripheral venous access.
15. The subject had undergone at least 200 mL of whole blood within the 28 days prior to the first dose of study medication, or at least 400 mL of whole blood within the 84 days prior to the first dose of study medication.
16. The subject had undergone at least 800 mL in total of whole blood within the 364 days prior to the first dose of study medication.
17. The subject had undergone blood components collection within 14 days prior to the first dose of study medication.
18. Subject had a clinically significant ECG abnormality at screening or check-in (Day -1).
19. Subject had abnormal screening laboratory values that suggested a clinically significant disease or the following laboratory abnormalities at screening:
- Creatinine > 2 mg/
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma concentrations and urinary excretion ratios of TAK-438 free base (TAK-438F) and its major metabolites (M-I, M-II, M-III, and M-IV-Sul).<br>Timeframe; 11 Days
- Secondary Outcome Measures
Name Time Method Adverse events (AEs), clinical laboratory test values, electrocardiogram (ECG) findings, vital signs, and serum gastrin and pepsinogen I/II levels.<br>Timeframe; 11 Days