Pharmacokinetic/Pharmacodynamic Study of Ilaprazole to Evaluate the Effect of CYP Genetic Polymorphism

Sponsor

Inje University (Other)

Overall Status

Completed

CT.gov ID

NCT01688544

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Ilaprazole is a novel proton pump inhibitor and metabolized by CYP3A4 and 2C19. Thus genetic polymorphisms of CYP3A4 and 2C19 may have effect on the pharmacokinetics and pharmacodynamics of Ilaprazole.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Ilaprazole	Phase 1

Detailed Description

Effects of genetic polymorphisms on the pharmacokinetics or pharmacodynamics were measured in healthy Korean volunteers

Study Design

Study Type:

Interventional

Actual Enrollment :

27 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Phase 1 Study to Evaluate the Effect of CYP Polymorphism and Gender on the Pharmacokinetics and Pharmacodynamics of Ilaprazole After Multiple Dosing

Study Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ilaprazole Before Ilaprazole dosing, 24 hours intragastric pH monitoring is performed as baseline value. After 7 days dosing of Ilaprazole 10 mg, 24 hours intragastric pH monitoring, serum gastrin level check, and pharmacokinetic sampling is performed	Drug: Ilaprazole Ilaprazole 10 mg for 7 days Other Names: 2-[(4methoxy-3-methyl)-2-pyridinyl] methylsulfinyl- 5-(1H-pyrrol-1yl)-1H-benzimidazole

Arm

Intervention/Treatment

Experimental: Ilaprazole

Before Ilaprazole dosing, 24 hours intragastric pH monitoring is performed as baseline value. After 7 days dosing of Ilaprazole 10 mg, 24 hours intragastric pH monitoring, serum gastrin level check, and pharmacokinetic sampling is performed

Drug: Ilaprazole

Ilaprazole 10 mg for 7 days

Other Names:

2-[(4methoxy-3-methyl)-2-pyridinyl] methylsulfinyl-

5-(1H-pyrrol-1yl)-1H-benzimidazole

Outcome Measures

Primary Outcome Measures

24 hour intragastric ph [After 7 days dosing of Ilaprazole 10 mg]

Secondary Outcome Measures

Pharmacokinetic parameters (Cmax, AUC) of Ilaprazole and its metabolite [After 7 days dosing of Ilaprazole]
Serum Gastrin level [After 7 days dosing of Ilaprazole]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

healthy adult volunteer between 20 and 45 years of age and within 20% of ideal body weight
No congenital or acquired chronic disease
appropriate for the study judging from examinations (hematology, chemistry, urinalysis and so on), vital sign and ECG results
sign the informed consent form prior to study participation

Exclusion Criteria:

received any metabolizing enzymes or transporters inducing or inhibiting drugs like barbiturates within 1 month prior to the date of first drug administration
history of hypersensitivity against drugs or clinically significant allergic diseases
abnormal laboratory results
positive result for helicobacter pylori infection from the Urea Breath Test
alcohol or drug abuser
pregnant or lactating
donated whole blood within 60days prior to the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Inje University Busan Paik Hoapital Clinical Trial Center	Busan		Korea, Republic of	614-735

Sponsors and Collaborators

Inje University

Investigators

Principal Investigator: JaeGook Shin, MD,PhD, Inje University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jae-Gook Shin, Department of Pharmacology and Pharmacogenomics Research Center, Inje University

ClinicalTrials.gov Identifier:

NCT01688544

Other Study ID Numbers:

08-112

First Posted:

Sep 20, 2012

Last Update Posted:

Sep 20, 2012

Last Verified:

Sep 1, 2012

Keywords provided by Jae-Gook Shin, Department of Pharmacology and Pharmacogenomics Research Center, Inje University

Additional relevant MeSH terms:

Benzimidazole

Study Results

No Results Posted as of Sep 20, 2012