Overview

TAK-438 - Safety, Blood Levels & Effects of Repeated Doses

Status:
Completed
Trial end date:
2009-02-01
Target enrollment:
0
Participant gender:
Male
Summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of TAK-438 in healthy, non-Japanese men male subjects following a randomized, double blind, placebo controlled, sequential panel, multiple-dose schedule.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Takeda
Criteria
Inclusion Criteria:

- Male subjects aged 18 to 45, inclusive, who are in good health, as determined by
medical history, physical examination, clinical laboratory evaluations and urine drug
screen.

- The subject has the ability to tolerate the pH probe for 24 hours prior to
Randomization (Day 1).

Exclusion Criteria:

- Clinically significant history of hypersensitivity to any drug or food or any
excipients of TAK-438

- History of gastroesophageal reflux disease (GERD), symptomatic GERD, erosive
esophagitis, duodenal ulcer,gastric ulcer, dyspepsia, Barrett's esophagus, or
Zollinger-Ellison syndrome

- The subject has a positive test result for Helicobacter pylori at the Initial
Screening Visit

- Any clinically significant results from physical examinations or clinical laboratory
results as deemed by the investigator.