Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-03-01 @ 12:32 PM
Study NCT ID:
NCT02774902
Status:
COMPLETED
Last Update Posted:
2016-05-17
First Post:
2016-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TAK-438_110 Drug Interaction With Cytochrome P450 3A4 (CYP3A4) Inhibitor Clarithromycin
Sponsor:
Takeda
Organization:
Study Overview
Official Title:
A Phase 1, Open-Label, Sequential Design Study to Evaluate the Effect of Multiple Oral Doses of Clarithromycin on the Pharmacokinetics of a Single Oral Dose of TAK-438
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: