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.