TAK-438 - Safety, Blood Levels & Effects of Repeated Doses (TAK-438_107)

Takeda

Status and phase: Completed; Phase 1

Conditions: Gastroesophageal Reflux Disease (GERD); Erosive Esophagitis(EE)

Treatments: Drug: TAK-438 Placebo; Drug: TAK-438

Study type: Interventional

Funder types: Industry

Identifiers

NCT02141711

U1111-1153-8443 (Other Identifier)

TAK-438_107

2008-004975-22 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

The drug being tested in this study is called TAK-438. TAK-438 is being tested to find a safe and well-tolerated dose. This study looked at pharmacokinetic (effect of the body on the drug) and pharmacodynamic properties (effect of the drug on the body) as well as look at lab results and side effects in people who took TAK-438. This study was designed as a randomized, sequential-panel, multiple repeat dose study.

The study population consisted of 4 Cohorts with 12 participants in each Cohort; with 9 participants randomized to receive a single dose of TAK-438, and 3 participants to receive placebo. Participants in each Cohort received a single dose of study drug once daily after a 10-hour fast. The starting dose was 10 mg followed by administrations of 20, 40, and 30 mg.

This single-centre trial was conducted in the United Kingdom. The overall time to participate in this study was up to 37 days. Participants made 2 visits to the clinic for screening, one 11-day period of confinement to the clinic, and 2 further visits after the confinement period. All participants were contacted by telephone 7 days after last dose of study drug for a follow-up assessment.

Enrollment: 48 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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48 participants in 5 patient groups, including a placebo group

Cohort 1: TAK-438 10 mg

Experimental group

Description:

TAK-438 10 mg tablets, orally, once, daily, for 7 days.

Treatment:

Drug: TAK-438

Cohort 2: TAK-438 20 mg

Experimental group

Description:

TAK-438 20 mg tablets, orally, once, daily, for 7 days.

Treatment:

Drug: TAK-438

Cohort 3: TAK-438 40 mg

Experimental group

Description:

TAK-438 40 mg tablets, orally, once, daily, for 7 days.

Treatment:

Drug: TAK-438

Cohort 4: TAK-438 30 mg

Experimental group

Description:

TAK-438 30 mg tablets, orally, once, daily, for 7 days.

Treatment:

Drug: TAK-438

Cohorts 1-4: Placebo

Placebo Comparator group

Description:

TAK-438 placebo-matching tablets, orally, once, daily, for 7 days.

Treatment:

Drug: TAK-438 Placebo