Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT02774902
Brief Summary:
The purpose of this study is to evaluate the effect of multiple oral doses of clarithromycin on the pharmacokinetics of TAK-438 and its metabolites in healthy male adult participants following a single oral dose of TAK-438.
Detailed Description:
The drug being tested in this study is called TAK-438. TAK 438 is being tested to assess the effect of multiple oral doses of clarithromycin on the pharmacokinetics of TAK-438.
The study will enroll approximately 16 healthy adult male participants of non-Japanese origin. Participants will be assigned:
* TAK-438 40 mg
* Clarithromycin 500 mg
All participants will be asked to take 2 tablet of TAK-438 20 mg orally, once on Days 1 and 8 along with Clarithromycin 500 mg, tablets, orally twice daily from Days 3 to 9.
This single center trial will be conducted in Europe. The overall time to participate in this study is maximum of 44 days. Participants will be confined to site for 10 days, and a final visit after 4 days after discharge from the unit for a follow-up assessment.
Study:
NCT02774902
Study Brief:
Protocol Section:
NCT02774902