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

NCT01688544 | Completed Phase 1 DMC

• 1 other identifier: 08-112
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Ilaprazole; Intragastric pH; Serum Gastrin; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• 24 hour intragastric ph

  After 7 days dosing of Ilaprazole 10 mg

Secondary Outcomes (2)

• Pharmacokinetic parameters (Cmax, AUC) of Ilaprazole and its metabolite

  After 7 days dosing of Ilaprazole

• Serum Gastrin level

  After 7 days dosing of Ilaprazole

Study Arms (1)

Ilaprazole

EXPERIMENTAL

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

Interventions

Ilaprazole DRUG

Ilaprazole 10 mg for 7 days

Also known as: 2-[(4methoxy-3-methyl)-2-pyridinyl] methylsulfinyl-, 5-(1H-pyrrol-1yl)-1H-benzimidazole

Ilaprazole

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inje University: lead

Study Sites (1)

Inje University Busan Paik Hoapital Clinical Trial Center

Busan, Busan, 614-735, South Korea

Location

MeSH Terms

Interventions

ilaprazole

Study Officials

• JaeGook Shin, MD,PhD

  Inje University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Pharmacology and Pharmacogenomics Research Center

Study Record Dates

• First Submitted: December 6, 2011
• First Posted: September 20, 2012
• Study Start: January 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: September 20, 2012

Record last verified: 2012-09

Locations

KR (1)