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Completed

NCT Number: NCT03085836

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

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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Key information

Conditions

Healthy Participants

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Zhongshan Hospital Fudan University

Shanghai, 200032, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Is a healthy adult male or female Chinese participant.
  • Is aged 18 to 45 years, inclusive, at the time of signing the informed consent form.
  • 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).
  • Is willing to abstain from caffeine and alcohol from 72 hours before first dose (Day 1) until the Follow-up Visit on Day 18.
  • Is willing to abstain from strenuous exercise from 72 hours before first dose (Day 1) until the Follow-up Visit on Day 18.
  • Is willing to provide a sample for pharmacogenetic analysis (for cytochrome [CYP2C19] genotyping).

Exclusion criteria

  • 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.
  • Is lactose intolerant or has a known hypersensitivity to any component of the formulation of TAK-438.
  • Has poor peripheral venous access.
  • 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.
  • 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.

Treatment and study plan

TAK-438

Drug

TAK-438 tablets.

Primary outcomes

  1. Cmax: Maximum Observed Plasma Concentration for Free Base of TAK-438 (TAK-438F) and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1

    Time frame: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose

  2. Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1

    Time frame: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose

  3. AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1

    Time frame: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose

  4. AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Tau Over the Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1

    Time frame: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose

  5. T1/2z: Terminal Disposition Half-life for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1

    Time frame: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose

  6. Cmax,ss: Maximum Observed Plasma Concentration, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9

    Time frame: Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dose

  7. Tmax, ss: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9

    Time frame: Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dose

  8. AUCτ,ss: Area Under the Plasma Concentration-time Curve During a Dosing Interval, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9

    Time frame: Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dose

  9. Aet: Total Amount of Drug Excreted in Urine From Time 0 to Time T for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1

    Time frame: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose

  10. Fe,t: Fraction of Drug Excreted in Urine From Time 0 to Time t for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1

    Time frame: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose

  11. CLr: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1

    Time frame: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose

  12. Aeτ: Amount of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9

    Time frame: Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dose

  13. Fe,τ: Fraction of Administered Dose of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9

    Time frame: Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dose

  14. CLR: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9

    Time frame: Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dose

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

An Open-Label, Single-center, Parallel, Phase 1 Study to Determine the Pharmacokinetics of Single- and Multiple- Oral Doses of TAK-438 10 mg and 20 mg in Healthy Adult Chinese Subjects

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 21, 2017
Registry last updated
Jan 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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