drugset / Trial / NCT02141698
Safety, Tolerability, and Pharmacokinetics of TAK-438 in Healthy Western Male Subjects, Preliminary Food Effect Analysis, and an Ethnic Comparison With Japanese Subjects
RandomizedSingle-groupQuadruple-blindTreatment
Summary
The primary purpose of this study was to evaluate the safety, tolerability, and pharmacokinetics of TAK-438 following single or multiple doses of TAK-438 in healthy Western men, to investigate the effect of food on the pharmacokinetics of TAK-438, and to compare the TAK-438 pharmacokinetics of Western with Japanese men.
Timeline
- Start
- 2007-10
- Primary completion
- 2008-02
- Completion
- 2008-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Esomeprazole | Small molecule | 40 mg | Oral |
| Subject | Vonoprazan | Other / unclassified | 1 mg | Oral |
| Subject | Vonoprazan | Other / unclassified | 5 mg | Oral |
| Subject | Vonoprazan | Other / unclassified | 10 mg | Oral |
| Subject | Vonoprazan | Other / unclassified | 15 mg | Oral |
| Subject | Vonoprazan | Other / unclassified | 20 mg | Oral |
| Subject | Vonoprazan | Other / unclassified | 30 mg | Oral |
| Subject | Vonoprazan | Other / unclassified | 40 mg | Oral |
Indications
No indication recorded.