Clinical trial NCT01159145: Study to Assess the Pharmacodynamics/Pharmacokinetics After Repeated Dosing of D961H 10 mg and Omeprazole 10 mg in Japanese Healthy Male Subjects
Official title: A Randomised, Single Blind, Two-way Cross-over, Single-centre Study to Assess the Pharmacodynamics (Intragastric pH) and Pharmacokinetics After Repeated Oral Administration of D961H 10 mg and Omeprazole 10 mg in Japanese Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacodynamics Study
Keywords: Healthy volunteer
Japanese males
homo-EM/hetero-EM/PM
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-07-09
Enrollment: 42
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to assess the pharmacodynamics (intragastric pH) after repeated oral administration of D961H 10 mg and omeprazole 10 mg in Japanese healthy male subjects who are classified by the genotype of CYP2C19 by the assessment of percentage of time with intragastric pH\>4 during 24 hours after dose on day 5.


Eligibility criteria: Inclusion Criteria:

* Healthy Japanese male subjects between 20 and 45 years of age
* Genotype of CYP2C19 has been known as the volunteer panel data
* H. pylori negative has been known by urea breath test as the volunteer panel data.

Exclusion Criteria:

* Significant clinical illness from the 2 weeks preceding the pre-entry visit to the randomisation, as judged by the investigator(s), eg, acute inflammatory disease which requires medical intervention
* Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease, as judged by the investigator(s), eg, sequelae of myocardial infarction, nephritis, hepatitis and cerebral infarction
* Past or present severe allergic disease, hypersensitivity to food or drugs (except for seasonal hay fever), or allergic symptoms requiring medical intervention (eg, anesthetics used at the intragastric pH measurement)

Primary outcomes:
measure: To assess the pharmacodynamics (intragastric pH) after repeated administration of D961H 10 mg and omeprazole 10 mg in Japanese healthy male subjects by the assessment of percentage of time with intragastric pH>4.
timeFrame: A range of 24 hrs
Secondary outcomes:
measure: To assess the pharmacodynamics (intragastric pH) after repeated administration of D961H 10 mg and omeprazole 10 mg by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median intragastric pH.
timeFrame: A range of 24 hrs
measure: To assess the pharmacokinetics after repeated administration of D961H 10 mg and omeprazole 10 mg by the assessment of plasma concentrations and AUCt, AUCt, Css,max, tmax, and t1/2 for D961H and omeprazole after dose on day 5.
timeFrame: A range of 24 hours
measure: To assess the safety and the tolerability after repeated administration of D961H 10 mg and omeprazole 10 mg by the assessment of adverse events, laboratory variables, pulse rate, blood pressure, body temperature and 12-lead ECG
timeFrame: Until last visit, 5-7 days after last dose
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca KK
name: Masataka Date, MD PhD
role: STUDY_DIRECTOR
affiliation: AstraZeneca KK
name: Ippei Ikushima, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: