Effect of Vecam 40/300 and Vecam 20/300 Compared to Omeprazole 20 mg on Gastric pH

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is designed to assess and compare the effect of Vecam 40/300, Vecam 20/300 and Omeprazole 20 mg (a standard FDA approved GERD treatment) on the control of gastric pH.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vecta Ltd.
• Treatments: Omeprazole

Criteria

Inclusion Criteria:

• Healthy, H. pylori negative status (by Urea Breath Test)

• Male or female subjects

• Age 18-55 years

• Able to tolerate the placement of a nasogastric pH probe at screening

• Baseline Gastric pH≤2

• Use of acceptable form of birth control in females with child-bearing potential

• Had not used any form of tobacco (e.g. smoking or chewing) for the last year

• Can swallow a size "00" capsule without difficulty

• Willing to comply with study protocol

• Signed Informed Consent form

Exclusion Criteria:

• BMI > 40

• Slow or poor Omeprazole metabolizers (heterozygous or homozygous, respectively) based on CYP2C19 genotyping test.

• Any significant history of / or concurrent gastrointestinal diseases or conditions such as:

• GERD

• Acute gastrointestinal bleeding

• Zollinger Ellison Syndrome or Gastric hypersecretory condition

• Known Barrett's esophagus

• Esophageal stricture

• Peptic ulcer disease (gastric or duodenal) or family history of peptic ulcer disease

• Gastric outlet obstruction

• Gastroparesis

• Significant medical history or concurrent illness as determined by the principal investigator

• Any medical disorder that alters the normal gastric acid secretion profile as determined by the principal investigator

• History of diabetes mellitus

• Significant laboratory abnormalities as determined by the principal investigator

• Known metabolic alkalosis, hypocalcemia, sodium restricted diet, hypokalemia, respiratory alkalosis

• Pregnant or lactating women

• Had been treated with any investigational drug or therapy or participated in a clinical trial within 30 days prior to entering the trial

• Use of any medication other than contraception or hormone replacement therapy; OTC drugs other than vitamins or occasional acetaminophen within 30 days prior to entering the trial or during the trial

• Use of NSAID medications within 30 days prior to entering the trial (e.g. Ibuprofen, Aspirin, Naproxen etc)

• Positive urine test for alcohol or other drugs

• Concurrent use of gastric anti-secretory drugs such as defined below:

• Use of a PPI 30 days prior to each stage or during the trial

• Use of H2RA 14 days prior to each stage or during the trial

• Concurrent use of antacids (including over-the-counter) 24 hours prior to each stage or during the trial

• Use of any medication that modifies gastric acid secretion 30 days prior to or during the trial.

• Had ingested grapefruit within 14 days of dose administration in any trial period

• Significant drug allergy or known hypersensitivity to any of the ingredients in the trial drugs Omeprazole, Succinic Acid or to Lidocaine

• Consumption of coffee within 48 hours of dose administration in any trial period.

• Had donated blood within 30 days of entering the trial

• Known positive serology for HBV, HCV or HIV

• Any reason which makes the subject a poor candidate based on the physician's discretion