A Pharmacokinetic Study of TAK-438 in Healthy Adult Chinese Participants

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-19

Study Completion Date

2017-08-17

Brief Summary

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The purpose of this study is to determine the pharmacokinetics (PK) of TAK-438 in healthy adult Chinese participants after both single and multiple dose administration.

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Detailed Description

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The drug being tested in this study is called TAK-438. TAK-438 is being tested in healthy participants in order to evaluate the PK of single and multiple oral dose.

The study will enroll approximately 36 healthy participants. Participants will be assigned to one of the three treatment groups:

* TAK-438 10 mg tablet once daily
* TAK-438 20 mg tablet once daily
* TAK-438 20 mg tablet twice daily All participants will be asked to take TAK-438 tablet at the same time on Day 1 and Days 3-9.

This single-centre trial will be conducted in China. The overall time to participate in this study is 18 days. Participants will remain confined to the clinic from Day 1 up to Day 11 and will be followed-up by telephone or visit on Day 18.

Conditions

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Healthy Participants

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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TAK-438 10 milligram (mg) Once Daily

TAK-438 10 mg, tablets, orally, once daily on Days 1, 3-9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.

Group Type EXPERIMENTAL

TAK-438

Intervention Type DRUG

TAK-438 tablets.

TAK-438 20 mg Once Daily

TAK-438 20 mg, tablets, orally, once daily on Days 1, 3-9. Participants were asked to fast for a minimum of 10 hours prior administration of assigned treatment.

Group Type EXPERIMENTAL

TAK-438

Intervention Type DRUG

TAK-438 tablets.

TAK-438 20 mg Twice Daily

TAK-438 20 mg, tablets, orally, once on Day 1 and twice daily on Days 3-9. Participants were asked to fast for a minimum of 10 hours prior to breakfast, followed by administration of assigned treatment 0.5 hours after breakfast and dinner.

Group Type EXPERIMENTAL

TAK-438

Intervention Type DRUG

TAK-438 tablets.

Interventions

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TAK-438

TAK-438 tablets.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Is a healthy adult male or female Chinese participant.
2. Is aged 18 to 45 years, inclusive, at the time of signing the informed consent form.
3. Weighs at least 50 kilogram (kg) and has a body mass index (BMI) between 19 and 26 kilogram per square meter (kg/m\^2), inclusive at Screening (Check-In Day -1).
4. Is willing to abstain from caffeine and alcohol from 72 hours before first dose (Day 1) until the Follow-up Visit on Day 18.
5. Is willing to abstain from strenuous exercise from 72 hours before first dose (Day 1) until the Follow-up Visit on Day 18.
6. Is willing to provide a sample for pharmacogenetic analysis (for cytochrome \[CYP2C19\] genotyping).

Exclusion Criteria

1. Has uncontrolled, clinically significant cardiovascular disease or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results.
2. Is lactose intolerant or has a known hypersensitivity to any component of the formulation of TAK-438.
3. Has poor peripheral venous access.
4. Has donated or lost 400 milliliter (mL) or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 90 days prior to Day 1; or participant has donated or lost more than 200 mL or more of his or her blood in the last 28 days.
5. Has a history of symptomatic gastroesophageal reflux disease (GERD), Erosive Esophagitis, duodenal ulcer (DU), gastric ulcer (GU), dyspepsia, Barrett's Esophagus, or Zollinger-Ellison (ZE) syndrome or has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes