Efficacy and Safety of DLBS2411 in Healthy Volunteers

Study Overview
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Brief Summary
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This is a 3-arm, double-blind, randomized, controlled, parallel and dose ranging clinical study for 3 days of therapy to investigate the effect of DLBS2411 in gastric pH regulation as well as its safety in healthy volunteers. DLBS2411 has similar mechanism of action with proton-pump inhibitors (PPIs). However, it is hypothetically more potential than PPIs in suppressing gastric acid as our previous preclinical studies with DLBS2411 have proven its effects not only on the activity of H+/K+ ATPase, the enzyme that regulates proton pump in stomach, but also on its gene expression. It is hypothesized that DLBS2411 may benefit on gastric pH regulation in healthy volunteers.

Detailed Description
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There will be 3 groups of treatment; each group will consist of 18 subjects with the treatment regimens : Treatment I : 1 caplet of DLBS2411 250 mg and 1 placebo caplet of DLBS2411, once daily Treatment II : 2 caplets of DLBS2411 250 mg, once daily Treatment III : 2 placebo caplets of DLBS2411, once daily Clinical examination to evaluate the investigational drug's efficacy will be performed by a 24-hour-gastric pH monitoring after the first dose of study drug administration. Besides, the pH of the gastric fluid will also be measured at the end of study (Day 3 of treatment). Safety examination will be performed at baseline and at end of study. The occurrence of adverse event will be observed during the study. All subjects will be under direct supervision of a medical doctor during the study period.

Official Title
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Effect of DLBS2411 on Gastric pH Regulation in Healthy Volunteers : Comparison With Placebo

Conditions
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Gastric pH Regulation in Healthy Volunteers

Intervention / Treatment
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* Drug: DLBS2411
* Drug: DLBS2411
* Drug: Placebo DLBS2411


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male subjects with age of 18-45 years Healthy as confirmed by vital signs, clinical and laboratory assessments (normal blood pressure, normal plasma glucose level, normal values of all hematological parameters, adequate liver and renal function) BMI 18-25 kg/m2 Able to take oral medication Exclusion Criteria: Gastric pH ≥ 4 at screening Currently being an active smoker and suffering from chronic alcoholism History of or currently peptic ulcer Having clinical diagnosis of Zollinger Ellison syndrome Taking any H2RAs, PPIs, antacids, or gastric mucosal protectors within 2 weeks prior to screening Taking any other medicines, supplements, or herbals within 3 days prior to screening History of gastro-intestinal disturbances necessitating long-term treatment with any acid suppressing medication, antacids, or gastric mucosal protectors The presence of any chronic diseases Currently being afflicted by serious infection(s) Participation in any other clinical studies within 30 days prior to screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment 1<br>one dose of DLBS2411 @250 mg | Drug: DLBS2411<br>* 1 caplet of DLBS2411 @250 mg and 1 placebo caplet, once daily<br>|
| Experimental: Treatment II<br>two doses of DLBS2411 @250 mg | Drug: DLBS2411<br>* 2 caplets of DLBS2411 @250 mg, once daily<br>|
| Placebo Comparator: Treatment III<br> | Drug: Placebo DLBS2411<br>* 2 placebo caplets of DLBS2411, once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of time over 24 hours during which gastric pH is > 4 | Percentage of time over 24 hours during which gastric pH is > 4 after a single dose of study medication | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The onset of action | The onset of action, which is defined as time taken to achieve gastric pH of > 4 after the initial dose of study medication | 24 hours | 
| 24-hour median gastric pH | 24-hour median gastric pH after the initial dose of study medication | 24 hours | 
| Gastric pH at the end of study | Gastric pH after a repeated (3-day) dosing of study medication | 3 days | 
| Change of ECG description from baseline | ECG will be evaluated at baseline (Day 1st)and at end of study (Day 3rd) | baseline and 3 days after treatment initiation | 
| Routine haematology | Routine haematology (hemoglobin level, hematocrit, erythrocyte count, leucocyte count, differentiation of WBC and platelet count) will be evaluated at baseline and at end of study (Day 3rd) | Baseline and 3 days after treatment initiation | 
| Liver function | Liver function (ALT, AST, γ-GT, and total bilirubin levels) will be evaluated at baseline and at end of study (Day 3rd) | baseline and 3 days after treatment initiation | 
| Renal function | Renal function (serum creatinine level) will be evaluated at baseline and at end of study (Day 3rd) | Baseline and 3 days after treatment initiation | 
| Urinalysis parameters | Urinalysis parameters (urine color, pH, presence of glucose, protein, sediments, epithelial cells, erythrocyte, leucocyte, and others) will be evaluated at baseline and at end of study (Day 3rd) | Baseline and 3 days after treatment initiation | 
| Adverse events | Type and number of adverse events as well as number of subjects experiencing the events will be observed and evaluated during study period (3 days of treatment)and until the end of study or all adverse events have been recovered or stabilized (which ever comes first). | 3 days or until all adverse events have been recovered or stabilized (which ever comes first) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Proton pump inhibitor (PPI), DLBS2411, gastric pH