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

NCT02141711 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2014-05-19

No results posted yet for this study

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.

Conditions

  • Erosive Esophagitis(EE)
  • Gastroesophageal Reflux Disease (GERD)

Interventions

DRUG

TAK-438

TAK-438 tablets

DRUG

TAK-438 Placebo

TAK-438 placebo-matching tablets

Sponsors & Collaborators

Principal Investigators

  • Medical Director Clinical Science · Takeda

  • Steve Warrington · Hammersmith Medicines Research

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02141711 on ClinicalTrials.gov