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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Ilaprazole

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 614-735
    • Inje University Busan Paik Hoapital Clinical Trial Center

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
24 hour intragastric ph	After 7 days dosing of Ilaprazole 10 mg

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetic parameters (Cmax, AUC) of Ilaprazole and its metabolite	After 7 days dosing of Ilaprazole
Serum Gastrin level	After 7 days dosing of Ilaprazole

Collaborators and Investigators

• Sponsor: Inje University

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: December 6, 2011
• First Submitted That Met QC Criteria: September 19, 2012
• First Posted (Estimate): September 20, 2012

Study Record Updates

• Last Update Posted (Estimate): September 20, 2012
• Last Update Submitted That Met QC Criteria: September 19, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Intragastric pH; Ilaprazole; Serum Gastrin
• Additional Relevant MeSH Terms: Anti-Infective Agents; Antiparasitic Agents; Anthelmintics; Benzimidazole
• Other Study ID Numbers: 08-112