Pharmacodynamic and Pharmacokinetic Study of E3710 Following Oral Administration to Healthy, Male, Japanese Subjects

NCT01390714 | Completed Phase 1

• 1 other identifier: E3710-A001-003
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the pharmacodynamics (PD) and pharmacokinetics of E3710 following oral administration to Healthy Male Japanese Subjects

Conditions

Gastroesophageal Reflux Disease

Keywords

Proton Pump Inhibitors; Gastroesophageal Reflux Disease; pharmacokinetics; pharmacodynamics

Outcome Measures

Primary Outcomes (3)

• Pharmacodynamic effect by ph monitoring will be evaluated.

  Summary statistics of the measurements and changes from pre-dose values to post-dose values of intragastric pH 1-, pH 2-, pH 3-, pH 4-, pH 5-, and pH 6 holding time, mean of the intragastric pH and median of intragastric pH are to be calculated by dose. In addition, the mean and median intragastric pH for the hours 1-14 and 14-24 (8:00-22:00 and 22:00-8:00) should be calculated for baseline and each pH-recording period.

  Day 1 and Day 5

• Pharmacokinetics parameters Cmax will be calculated.

  Summary statistics of E3710/RPZ/EPZ pharmacokinetic parameters on Day 1 and Day 5 of administration are to be calculated by dose. Relationship of Cmax to dose of E3710 is to be examined.

  4 weeks

• Pharmacokinetics parameter AUC will be calculated.

  Summary statistics of E3710/RPZ/EPZ pharmacokinetic parameters on Day 1 and Day 5 of administration are to be calculated by dose. Relationship of AUC to dose of E3710 is to be examined.

  4 weeks

Study Arms (2)

1

EXPERIMENTAL

Drug: E3710

2

EXPERIMENTAL

Drug: E3710

Interventions

E3710 DRUG

Arm A: 1. E3710 40 mg→RPZ 10 mg→E3710 20 mg 2. RPZ 10 mg→E3710 20 mg→E3710 40 mg 3. E3710 20 mg→E3710 40 mg→RPZ 10 mg Crossover study of E3710 40 mg, E3710 20 mg, and PRZ 10 mg, once daily, for 5 days, oral administration.

1

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects who received a full explanation about objectives and contents of this study and provided written consent to participate in this study by their own free will before the start of screening.
• Japanese, healthy, male adults, 20-40 years of age on the day of consent.
• Japanese subjects must be first generation Japanese (born in Japan of Japanese parents and Japanese grandparents), must have lived no more than 5 years outside of Japan and must not have changed their life style or habits, including diet, while living outside of Japan.
• CYP2C19 homo or heterozygous extensive metabolizers.
• Subjects who have no current infection with Helicobacter pylori (H. pylori).
• Subjects with body mass index (BMI) 18.5-25.0 kg/m2 at the time of screening.
• Subjects who received screening examination within 4 weeks before entering the Phase I unit in Stage 1 and were judged to be eligible for this study by the investigator.

You may not qualify if:

• Likely allergy or sensitivity to any components of E3710 based on known allergies to drugs of the same class (e.g. proton pumps inhibitors, specifically RPZ or EPZ) or which in the opinion of the Principal Investigator might increase the potential for adverse events.
• Subjects with present or previous history of drug allergy, food allergy or clinically problematic allergy (e.g. chronic asthma or urticaria).
• Subjects with diseases that may affect evaluation of the study drug such as gastrointestinal, hepatic, renal, respiratory, endocrine, blood, nervous, mental or cardiac vascular diseases or congenital metabolic disorders at the time of screening or within 4 weeks before hospitalization in each stage of the study.
• Subjects with history of surgical therapies (such as resection of the liver, the kidney or the digestive tracts) that may influence pharmacokinetics of the study drug.
• Subjects who had 10% or more of body weight changes during a period from screening to Day 1 of hospitalization in each stage of the study.
• Subjects who had beverages containing caffeine (such as coffee, tea, chocolate or cola) within 72 hours before hospitalization in each stage of the study.
• Subjects who had grapefruit juice or food and drinks containing grapefruit within 72 hours before hospitalization in each stage of the study.
• Subjects who had alcoholic beverages within 72 hours before hospitalization in each stage of the study.
• Subjects who cannot quit smoking during hospitalization.
• Subjects who performed vigorous exercise or hard labor (more than 1 hour in a day or 5 days or more in a week) within 2 weeks before hospitalization in each stage of the study.
• Subjects who are found to have abnormal clinical symptoms or organ function disorders requiring medical treatment in examinations of medical history, symptoms and signs, vital signs, ECG or laboratory tests.
• Subjects with QTC longer than 450 msec in 12-lead electrocardiography (Bazett's method).
• Subjects with history of alcohol or drug abuse, who are suspected to have such the history or who have positive reaction in urinary drug test at the time of screening or hospitalization of the study.
• Subjects who used any ethical drugs within 4 weeks before hospitalization in each stage of the study \*.
• Subjects who took any OTC drugs (including PPIs and H2-receptor antagonists), antacids, nutrients, vitamin preparations or preparations containing herb (including Chinese medicines and food products) within one week before hospitalization in each stage of the study. However, for the herb preparations, which are known to induce cytochrome P450, drug metabolizing enzyme (e.g. preparations and food products containing St. John's wort), subjects who took such the preparations within 4 weeks before hospitalization in each stage of the study.

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (1)

Unknown Facility

Glendale, California, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

2-(4-(2,2-dimethyl-1,3-dioxan-5-yl)methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl-1H-benzimidazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Mark Yen

  California Clinical Trials

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2011
• First Posted: July 11, 2011
• Study Start: July 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: March 14, 2012

Record last verified: 2012-03

Locations

US (1)