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

A Randomized, Open-label, Crossover, Pharmacokinetic and Pharmacodynamic Study of Z-215 Compared With Rabeprazole Sodium 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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Z-215 10mg; Drug: Z-215 20mg; Drug: Rabeprazole Sodium 10mg; Drug: Rabeprazole Sodium 20mg

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; 3-way cross-over, Z-215 10 mg/day / Z-215 20 mg/day / Rabeprazole Sodium 10 mg/day	Drug: Z-215 10mg; Z-215 10mg, capsules; Drug: Z-215 20mg; Z-215 20mg, capsules; Drug: Rabeprazole Sodium 10mg; Rabeprazole Sodium 10mg tablets
Experimental: 2; 3-way cross-over, Z-215 20 mg/day / Z-215 40 mg/day / Rabeprazole Sodium 20 mg/day	Drug: Z-215 20mg; Z-215 20mg, capsules; Drug: Rabeprazole Sodium 20mg; Rabeprazole Sodium 20mg tablets
Experimental: 3; 3-way cross-over, Z-215 20 mg/day (before breakfast) / Z-215 20 mg/day (after breakfast) / Rabeprazole Sodium 10 mg/day (after breakfast)	Drug: Z-215 20mg; Z-215 20mg, capsules; Drug: Rabeprazole Sodium 10mg; Rabeprazole Sodium 10mg tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24-Hour Intragastric pH Profile	Summary statistics of the measurements on Day1 and Day5 of administration are to be calculated by dose.	4 weeks
Cmax: Maximum Plasma Concentration for Z-215	Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.	4 weeks
tmax: Time to Reach Maximum Plasma Concentration (Cmax) for Z-215	Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.	4 weeks
t1/2: Terminal Elimination Half-life (t1/2) for Z-215	Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.	4 weeks
Lambda Z: Terminal Elimination Rate Constant (Lambda Z) for Z-215	Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.	4 weeks
AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Z-215	Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.	4 weeks
AUC0-24: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 hour for Z-215	Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.	4 weeks
AUC0-∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Z-215	Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.	4 weeks
CL/F: Apparent Total Body Clearance (CL/F) Pharmacokinetic Parameter for Z-215	Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.	4 weeks
Vd/F: Apparent Volume of Distribution (Vd/F) Pharmacokinetic Parameter for Z-215	Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.	4 weeks
MRT0-∞: Mean Residence Time from Time 0 to Infinity for Z-215	Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.	4 weeks
Rac(Cmax): Accumulation Index of Cmax (Rac(Cmax)) for Z-215	Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.	4 weeks
Rac(AUC): Accumulation Index of AUC (Rac(AUC)) for Z-215	Summary statistics of pharmacokinetic parameters on Day1 and Day5 of administration are to be calculated by dose.	4 weeks

Collaborators and Investigators

• Sponsor: Zeria Pharmaceutical

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: July 21, 2015
• First Submitted That Met QC Criteria: July 24, 2015
• First Posted (Estimate): July 28, 2015

Study Record Updates

• Last Update Posted (Estimate): September 22, 2016
• Last Update Submitted That Met QC Criteria: September 21, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Male Subjects
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Rabeprazole
• Other Study ID Numbers: Z215-02