Healthy Clinical Trial - Phase 3 Study to Evaluate the Acid-Inhibitory

Status Completed

Clinical Trial Summary

The purpose of this study is to investigate the acid-inhibitory effect of multiple oral doses of TAK-438 and the relative effect of TAK-438 versus two controls (esomeprazole and rabeprazole sodium) in healthy Japanese adult male participants with the CYP2C19 EM genotype.

Clinical Trial Description

This is a Phase 3 open-label crossover study to evaluate the acid-inhibitory effect following 7 days multiple doses of TAK-438 (20 mg per dose) and esomeprazole (20 mg per dose) (Cohort 1) or TAK-438 (20 mg per dose) and rabeprazole sodium (10 mg per dose) (Cohort 2) in healthy Japanese adult male participants (CYP2C19 genotype: EM). There will be a total of 20 subjects, 5 per group for both Cohorts 1 and 2. At least 2 subjects each with the homo EM (*1/*1) or hetero EM (*1/*2, *1/*3) CYP2C19 genotype will be enrolled among the 5 subjects per group.

The drug being tested in this study is called TAK-438. This study will look at the acid inhibitory effect following 7 days multiple doses of TAK-438 and esomeprazole (Cohort 1) or TAK-438 and rabeprazole sodium (Cohort 2) in healthy Japanese adult male participants witrh the CYP2C19 EM genotype.

The study will enroll a total of 20 participants, 5 per group for both Cohorts. At least 2 subjects each with the homo EM (*1/*1) or hetero EM (*1/*2, *1/*3) CYP2C19 genotype will be enrolled among the 5 subjects per group.

- Group A, Cohort 1: TAK-438 (20 mg per dose for 7 days) followed by esomeprazole (20 mg per dose for 7 days)

- Group B, Cohort 1: esomeprazole (20 mg per dose for 7 days) followed by TAK-438 (20 mg per dose for 7 days)

- Group C, Cohort 2: TAK-438 (20 mg per dose for 7 days) followed by rabeprazole sodium (10 mg per dose for 7 days)

- Group D, Cohort 2: rabeprazole sodium (10 mg per dose for 7 days) followed by TAK-438 (20 mg per dose for 7 days).

All participants will be asked to take Study Medication at the same time each day throughout the study. This single center trial will be conducted in Japan. The overall time to participate in this study is 31 days. ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Healthy

Clinical Trial Details

NCT number	NCT02037477
Study type	Interventional
Source	Takeda
Contact
Status	Completed
Phase	Phase 3
Start date	January 2014
Completion date	March 2014

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Phase 3 Study to Evaluate the Acid-Inhibitory Effect of Multiple Oral Doses of TAK-438

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms