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

NCT02509923 | Completed Phase 1

• 1 other identifier: Z215-02
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Male Subjects

Outcome Measures

Primary Outcomes (13)

• 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

Study Arms (3)

1

EXPERIMENTAL

3-way cross-over, Z-215 10 mg/day / Z-215 20 mg/day / Rabeprazole Sodium 10 mg/day

Drug: Z-215 10mg; Drug: Z-215 20mg; Drug: Rabeprazole Sodium 10mg

2

EXPERIMENTAL

3-way cross-over, Z-215 20 mg/day / Z-215 40 mg/day / Rabeprazole Sodium 20 mg/day

Drug: Z-215 20mg; Drug: Rabeprazole Sodium 20mg

3

EXPERIMENTAL

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; Drug: Rabeprazole Sodium 10mg

Interventions

Z-215 10mg DRUG

Z-215 10mg, capsules

1

Z-215 20mg DRUG

Z-215 20mg, capsules

1; 2; 3

Rabeprazole Sodium 10mg DRUG

Rabeprazole Sodium 10mg tablets

1; 3

Rabeprazole Sodium 20mg DRUG

Rabeprazole Sodium 20mg tablets

2

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zeria Pharmaceutical: lead

Study Sites (1)

Unknown Facility

Tokyo, Japan

Location

MeSH Terms

Interventions

Rabeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2015
• First Posted: July 28, 2015
• Study Start: July 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 22, 2016

Record last verified: 2016-09

Locations

JP (1)