Completed

NCT Number: NCT01159145

Study to Assess the Pharmacodynamics/Pharmacokinetics After Repeated Dosing of D961H 10 mg and Omeprazole 10 mg in Japanese Healthy Male Subjects

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.

Completed

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Key information

Conditions

Pharmacodynamics Study

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Tokyo, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

D961H

Drug

Oral, capsule

Omeprazole

Drug

Oral, tablet

Primary outcomes

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.

Time frame: A range of 24 hrs

Secondary outcomes

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.

Time frame: A range of 24 hrs
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.

Time frame: A range of 24 hours
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

Time frame: Until last visit, 5-7 days after last dose

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: Jul 9, 2010
Registry last updated: Sep 21, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.