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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02509923
• Other study ID #: Z215-02
• Status: Completed
• Phase: Phase 1
• First received: July 21, 2015
• Last updated: September 21, 2016
• Start date: July 2015
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Zeria Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: September 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Z-215 10mg
Z-215 10mg, capsules
• Z-215 20mg
Z-215 20mg, capsules
• Rabeprazole Sodium 10mg
Rabeprazole Sodium 10mg tablets
• Rabeprazole Sodium 20mg
Rabeprazole Sodium 20mg tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zeria Pharmaceutical

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-Hour Intragastric pH Profile	Summary statistics of the measurements on Day1 and Day5 of administration are to be calculated by dose.	4 weeks	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	AUC0-8: 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	No
Primary	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	No
Primary	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	No
Primary	MRT0-8: 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	No
Primary	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	No
Primary	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	No