Clinical trial NCT02509923: To Evaluate Pharmacokinetics and Pharmacodynamics of Z-215 in Healthy Male Subjects
Official title: A Randomized, Open-label, Crossover, Pharmacokinetic and Pharmacodynamic Study of Z-215 Compared With Rabeprazole Sodium in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Male Subjects
Lead sponsor: Zeria Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2015-07-28
Enrollment: 54
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 24-Hour Intragastric pH Profile
timeFrame: 4 weeks
measure: Cmax: Maximum Plasma Concentration for Z-215
timeFrame: 4 weeks
measure: tmax: Time to Reach Maximum Plasma Concentration (Cmax) for Z-215
timeFrame: 4 weeks
measure: t1/2: Terminal Elimination Half-life (t1/2) for Z-215
timeFrame: 4 weeks
measure: Lambda Z: Terminal Elimination Rate Constant (Lambda Z) for Z-215
timeFrame: 4 weeks
measure: AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Z-215
timeFrame: 4 weeks
measure: AUC0-24: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 hour for Z-215
timeFrame: 4 weeks
measure: AUC0-∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Z-215
timeFrame: 4 weeks
measure: CL/F: Apparent Total Body Clearance (CL/F) Pharmacokinetic Parameter for Z-215
timeFrame: 4 weeks
measure: Vd/F: Apparent Volume of Distribution (Vd/F) Pharmacokinetic Parameter for Z-215
timeFrame: 4 weeks
measure: MRT0-∞: Mean Residence Time from Time 0 to Infinity for Z-215
timeFrame: 4 weeks
measure: Rac(Cmax): Accumulation Index of Cmax (Rac(Cmax)) for Z-215
timeFrame: 4 weeks
measure: Rac(AUC): Accumulation Index of AUC (Rac(AUC)) for Z-215
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
References: