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Dose-Effect of S-Tenatoprazole-Na(STU-Na) 30 mg, 60 mg, 90 mg and 120 mg in Healthy Volunteers

Primary Purpose

Esophagitis, Gastroesophageal Reflux, Stomach Ulcer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
S-Tenatoprazole-Na (STU-Na)
Sponsored by
STEBA France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophagitis focused on measuring S-Tenatoprazole-Na, Pharmacokinetic, intragastric pH recording, dose-response

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: Healthy male volunteers aged 18 to 55 years inclusive Able to understand the nature of the study and to give written informed consent Able to communicate well with the investigator himself or his/her representatives Able not to smoke during each hospitalization Normal physical examination at the screening visit Body Mass Index between 18 kg/m² and 35 kg/m² at the screening visit Normal blood pressure and heart rate measured under standardized conditions at the screening visit after at least 5 minutes of rest in a supine position: SBP within 90 and 140 mmHg, DBP within 40 and 85 mmHg, and HR within 40 to 85 bpm Normal 12-lead electrocardiogram at screening visit recorded after at least 5 minutes of rest: PR within 120 and 200 ms, QRS below or equal to 120 ms, and QTc below or equal to 440 ms Laboratory results within the normal ranges or considered not being of clinical relevance by the investigator Exclusion Criteria: Vegetarians Positive to H. pylori by 13C urea breath test or stool antigen test at screening visit Contra-indication to proton pump inhibitors treatment Previous participation in a trial with PPIs within 3 months Current or historical evidence of clinically relevant cardiovascular, neurological, hematological, hepatic, gastrointestinal, renal, pulmonary, endocrinological, metabolic or psychiatric disease Any other acute or chronic disease which could influence the volunteer's health and/or the study results Presence or history of malabsorption or any gastrointestinal surgery except appendectomy or hernia repair Receipt of medication (including 'over the counter' preparations) within two weeks of dosing Use of enzyme inducers or enzyme inhibitor drugs within the last three months before the first drug administration Participation in a clinical trial involving receipt of a licensed (marketed) medicinal product or of an unlicensed (investigational) medicinal product within one month before the study Past or current drug exposure amounting to drug abuse or addiction Past or current alcohol exposure amounting to alcohol abuse or addiction; (i.e. > 28 units per week for males, where 1 unit = one measure of spirit (25 mL), one glass of wine (125 mL) or ½ pint beer) Currently smoke >10 cigarettes per day Donation of blood or any other major blood loss (>500 mL) within three months before the study Unwilling or unable to comply with the study protocol for any reason or in the opinion of the investigator should not participate in the study Positive test for hepatitis B surface antigen, hepatitis C antibody, HIV1 or HIV2 antibody at screening Known allergy or intolerance to lactose Known allergy or intolerance to any other compound in the study drug or any other closely related compound

Sites / Locations

  • Healthcare Discoveries, Inc.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

I STU-Na

Arm Description

Cross-over study with escalating doses

Outcomes

Primary Outcome Measures

Intragastric pH recording for 24 hours after 5 days of treatment

Secondary Outcome Measures

Pharmacokinetic blood sampling at steady state

Full Information

First Posted
January 31, 2006
Last Updated
March 21, 2008
Sponsor
STEBA France
Collaborators
STEBA LABORATORIES LTD.
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1. Study Identification

Unique Protocol Identification Number
NCT00284908
Brief Title
Dose-Effect of S-Tenatoprazole-Na(STU-Na) 30 mg, 60 mg, 90 mg and 120 mg in Healthy Volunteers
Official Title
Pharmacodynamic Dose-Response of S-Tenatoprazole-Na (STU-Na) 30 mg, 60 mg, 90 mg and 120 mg in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
STEBA France
Collaborators
STEBA LABORATORIES LTD.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
S-Tenatoprazole-Na (STU-Na), a new drug currently under clinical development, belongs to a class of drugs, called proton pump inhibitors (PPls). Some PPIs are already commercially available. STU-Na will be used for treatment of acid related diseases (gastroduodenal ulcers, erosive or ulcerative esophagitis due to gastroesophageal reflux disease). This study evaluates the degree of acid suppression by different doses of STU-Na. The degree of acid suppression is considered to be correlated with clinical efficacy. In this study four dosages of STU-Na (30 mg, 60 mg, 90 mg, and 120 mg) will be tested in each volunteer. First, one of the dosages will be orally administered for five days. Then, a nine to sixteen day period without study drug administration will follow prior to the administration of the next dosage, for again five days. Each volunteer will have a total of four study drug administration periods. After the last study drug intake in period 1, 2 and 3 pharmacokinetic blood sampling will be done for four days. After the last study drug intake in period 4 pharmacokinetic blood sampling will be done for five days. Pharmacokinetic blood sampling consists of several blood draws over a pre-determined time period. The pharmacokinetic blood sampling measures the medication concentration in the blood at pre-defined time points. After the last study drug intake in period 1, 2, 3, and 4, gastric acidity will be measured for 24 hours by means of a thin tube that will be inserted into the stomach through the nostril to evaluate the efficacy of the different dosages of STU-Na.
Detailed Description
S-Tenatoprazole-Na (STU-Na), a new drug currently under clinical development, belongs to a class of drugs, called proton pump inhibitors (PPls). Some PPIs are already commercially available. STU-Na will be used for treatment of acid related diseases (gastroduodenal ulcers, erosive or ulcerative esophagitis due to gastroesophageal reflux disease). This study evaluates the degree of acid suppression by different doses of STU-Na. The degree of acid suppression is considered to be correlated with clinical efficacy. In this study four dosages of STU-Na (30 mg, 60 mg, 90 mg, and 120 mg) will be tested in each volunteer. First, one of the dosages will be orally administered for five days. Then, a nine to sixteen day period without study drug administration will follow prior to the administration of the next dosage, for again five days. Each volunteer will have a total of four study drug administration periods. After the last study drug intake in period 1, 2 and 3 pharmacokinetic blood sampling will be done for four days. After the last study drug intake in period 4 pharmacokinetic blood sampling will be done for five days. Pharmacokinetic blood sampling consists of several blood draws over a pre-determined time period. The pharmacokinetic blood sampling measures the medication concentration in the blood at pre-defined time points. After the last study drug intake in period 1, 2, 3, and 4, gastric acidity will be measured for 24 hours by means of a thin tube that will be inserted into the stomach through the nostril to evaluate the efficacy of the different dosages of STU-Na.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophagitis, Gastroesophageal Reflux, Stomach Ulcer, Duodenal Ulcer
Keywords
S-Tenatoprazole-Na, Pharmacokinetic, intragastric pH recording, dose-response

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I STU-Na
Arm Type
Experimental
Arm Description
Cross-over study with escalating doses
Intervention Type
Drug
Intervention Name(s)
S-Tenatoprazole-Na (STU-Na)
Intervention Description
30 mg, 60 mg, 90 mg and 120 mg of STU-Na for 5 days every morning
Primary Outcome Measure Information:
Title
Intragastric pH recording for 24 hours after 5 days of treatment
Time Frame
Beginning of the pH recording before the last study drug intake in each period
Secondary Outcome Measure Information:
Title
Pharmacokinetic blood sampling at steady state
Time Frame
Blood sampling begins before the intake of the last study drug in each period and lasts for 96 hours (periods 1 to 3) or 120 hours (period 4)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy male volunteers aged 18 to 55 years inclusive Able to understand the nature of the study and to give written informed consent Able to communicate well with the investigator himself or his/her representatives Able not to smoke during each hospitalization Normal physical examination at the screening visit Body Mass Index between 18 kg/m² and 35 kg/m² at the screening visit Normal blood pressure and heart rate measured under standardized conditions at the screening visit after at least 5 minutes of rest in a supine position: SBP within 90 and 140 mmHg, DBP within 40 and 85 mmHg, and HR within 40 to 85 bpm Normal 12-lead electrocardiogram at screening visit recorded after at least 5 minutes of rest: PR within 120 and 200 ms, QRS below or equal to 120 ms, and QTc below or equal to 440 ms Laboratory results within the normal ranges or considered not being of clinical relevance by the investigator Exclusion Criteria: Vegetarians Positive to H. pylori by 13C urea breath test or stool antigen test at screening visit Contra-indication to proton pump inhibitors treatment Previous participation in a trial with PPIs within 3 months Current or historical evidence of clinically relevant cardiovascular, neurological, hematological, hepatic, gastrointestinal, renal, pulmonary, endocrinological, metabolic or psychiatric disease Any other acute or chronic disease which could influence the volunteer's health and/or the study results Presence or history of malabsorption or any gastrointestinal surgery except appendectomy or hernia repair Receipt of medication (including 'over the counter' preparations) within two weeks of dosing Use of enzyme inducers or enzyme inhibitor drugs within the last three months before the first drug administration Participation in a clinical trial involving receipt of a licensed (marketed) medicinal product or of an unlicensed (investigational) medicinal product within one month before the study Past or current drug exposure amounting to drug abuse or addiction Past or current alcohol exposure amounting to alcohol abuse or addiction; (i.e. > 28 units per week for males, where 1 unit = one measure of spirit (25 mL), one glass of wine (125 mL) or ½ pint beer) Currently smoke >10 cigarettes per day Donation of blood or any other major blood loss (>500 mL) within three months before the study Unwilling or unable to comply with the study protocol for any reason or in the opinion of the investigator should not participate in the study Positive test for hepatitis B surface antigen, hepatitis C antibody, HIV1 or HIV2 antibody at screening Known allergy or intolerance to lactose Known allergy or intolerance to any other compound in the study drug or any other closely related compound
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis A Ruff, MD
Organizational Affiliation
Healthcare Discoveries Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patrick Cohen, MD
Organizational Affiliation
STEBA France
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Christof Kreutz, MD
Organizational Affiliation
STEBA France
Official's Role
Study Director
Facility Information:
Facility Name
Healthcare Discoveries, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
2142113
Citation
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Results Reference
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PubMed Identifier
10364004
Citation
DeVault KR, Castell DO. Updated guidelines for the diagnosis and treatment of gastroesophageal reflux disease. The Practice Parameters Committee of the American College of Gastroenterology. Am J Gastroenterol. 1999 Jun;94(6):1434-42. doi: 10.1111/j.1572-0241.1999.1123_a.x. No abstract available.
Results Reference
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PubMed Identifier
15456460
Citation
Armstrong D. Review article: gastric pH -- the most relevant predictor of benefit in reflux disease? Aliment Pharmacol Ther. 2004 Oct;20 Suppl 5:19-26; discussion 38-9. doi: 10.1111/j.1365-2036.2004.02140.x.
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PubMed Identifier
1397746
Citation
Bell NJ, Burget D, Howden CW, Wilkinson J, Hunt RH. Appropriate acid suppression for the management of gastro-oesophageal reflux disease. Digestion. 1992;51 Suppl 1:59-67. doi: 10.1159/000200917.
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PubMed Identifier
15023167
Citation
Galmiche JP, Bruley Des Varannes S, Ducrotte P, Sacher-Huvelin S, Vavasseur F, Taccoen A, Fiorentini P, Homerin M. Tenatoprazole, a novel proton pump inhibitor with a prolonged plasma half-life: effects on intragastric pH and comparison with esomeprazole in healthy volunteers. Aliment Pharmacol Ther. 2004 Mar 15;19(6):655-62. doi: 10.1111/j.1365-2036.2004.01893.x.
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Citation
Horn J. The proton-pump inhibitors: similarities and differences. Clin Ther. 2000 Mar;22(3):266-80; discussion 265. doi: 10.1016/S0149-2918(00)80032-6.
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Citation
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Dose-Effect of S-Tenatoprazole-Na(STU-Na) 30 mg, 60 mg, 90 mg and 120 mg in Healthy Volunteers

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