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

NCT01159145 | Completed Phase 1

• 1 other identifier: D961HC00009
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharmacodynamics Study

Keywords

Healthy volunteer; Japanese males; homo-EM/hetero-EM/PM

Outcome Measures

Primary Outcomes (1)

• 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.

  A range of 24 hrs

Secondary Outcomes (3)

• 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.

  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.

  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

  Until last visit, 5-7 days after last dose

Study Arms (2)

D961H 10 mg capsule

EXPERIMENTAL

2 way crossover

Drug: D961H

Omeprazole 10 mg tablet

EXPERIMENTAL

2 way crossover

Drug: Omeprazole

Interventions

D961H DRUG

Oral, capsule

D961H 10 mg capsule

Omeprazole DRUG

Oral, tablet

Omeprazole 10 mg tablet

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Tokyo, Tokyo, Japan

Location

MeSH Terms

Interventions

Omeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Masataka Date, MD PhD

  AstraZeneca KK

  STUDY DIRECTOR

• Ippei Ikushima, MD, PhD

  AstraZeneca KK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 8, 2010
• First Posted: July 9, 2010
• Study Start: July 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: September 21, 2010

Record last verified: 2010-09

Locations

JP (1)