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Completed

NCT Number: NCT02509923

To Evaluate Pharmacokinetics and Pharmacodynamics of Z-215 in Healthy Male Subjects

The purpose of this study is to evaluate pharmacokinetics and pharmacodynamics of Z-215 (10 mg, 20 mg, 40 mg) , compared with Rabeprazole Sodium (10 mg, 20 mg ) in Healthy Male Subjects. And to evaluate food-effect in Healthy Male Subjects administrated Z-215 20 mg.

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Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Tokyo, Japan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Has negative results for H. pylori IgG antibody at screening.
  • A body mass index 18.5≦BMI<25.0 kg/m^2 at screening.
  • Able to understand the consent of the study and comply with the study. Able to give informed consent in writing before participating in the study.

Exclusion criteria

  • Has a history of PPI allergy.
  • Has a history of drug or food serious allergy.
  • Presently has or has a history of diseases that may affect evaluation of the study results such as gastrointestinal, hepatic, renal, respiratory, endocrine, blood, cardiovascular, mental or congenial metabolic disease.
  • Has a history of surgery (such as resection of the liver, kidney, or digestive tract) that may affect the pharmacokinetics of the study drug.
  • History of previous and current acid-related diseases.
  • Received H. pylori eradication treatment within 6 months before screening.
  • Has 450msec<QTC by Fridericia test at screening ECG .
  • Has hypoacidity or anacidity. Or be determined that low gastric acid or no stomach acid by the gastric pH monitoring at baseline period.
  • History or suspicion of drug, opioid, alcohol abuse or positive screening results.
  • Use of any prescription drugs within 4 weeks prior to baseline period.
  • Use of any over-the-counter drugs within 2 weeks prior to baseline period.
  • Received blood transfusions within 12 weeks or donated ≥400mL of whole blood within 12 weeks or ≥200mL of whole blood within 4 weeks prior to baseline period. Donated platelet or plasma within 2 weeks prior to baseline period.

Treatment and study plan

Z-215 10mg

Drug

Z-215 10mg, capsules

Z-215 20mg

Drug

Z-215 20mg, capsules

Rabeprazole Sodium 10mg

Drug

Rabeprazole Sodium 10mg tablets

Rabeprazole Sodium 20mg

Drug

Rabeprazole Sodium 20mg tablets

Primary outcomes

  1. 24-Hour Intragastric pH Profile

    Time frame: 4 weeks

    Summary statistics of the measurements on Day1 and Day5 of administration are to be calculated by dose.

  2. Cmax: Maximum Plasma Concentration for Z-215

    Time frame: 4 weeks

    Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.

  3. tmax: Time to Reach Maximum Plasma Concentration (Cmax) for Z-215

    Time frame: 4 weeks

    Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.

  4. t1/2: Terminal Elimination Half-life (t1/2) for Z-215

    Time frame: 4 weeks

    Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.

  5. Lambda Z: Terminal Elimination Rate Constant (Lambda Z) for Z-215

    Time frame: 4 weeks

    Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.

  6. AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Z-215

    Time frame: 4 weeks

    Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.

  7. AUC0-24: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 hour for Z-215

    Time frame: 4 weeks

    Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.

  8. AUC0-∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Z-215

    Time frame: 4 weeks

    Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.

  9. CL/F: Apparent Total Body Clearance (CL/F) Pharmacokinetic Parameter for Z-215

    Time frame: 4 weeks

    Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.

  10. Vd/F: Apparent Volume of Distribution (Vd/F) Pharmacokinetic Parameter for Z-215

    Time frame: 4 weeks

    Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.

  11. MRT0-∞: Mean Residence Time from Time 0 to Infinity for Z-215

    Time frame: 4 weeks

    Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.

  12. Rac(Cmax): Accumulation Index of Cmax (Rac(Cmax)) for Z-215

    Time frame: 4 weeks

    Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.

  13. Rac(AUC): Accumulation Index of AUC (Rac(AUC)) for Z-215

    Time frame: 4 weeks

    Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.

Sponsors and collaborators

Lead sponsor

Zeria Pharmaceutical

Industry

Registry information

Official study title

A Randomized, Open-label, Crossover, Pharmacokinetic and Pharmacodynamic Study of Z-215 Compared With Rabeprazole Sodium in Healthy Male Subjects

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 28, 2015
Registry last updated
Sep 22, 2016

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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