Efficacy and Safety of DLBS2411 in Healthy Volunteers

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

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.

Study Overview

• Status: Completed
• Conditions: Gastric pH Regulation in Healthy Volunteers
• Intervention / Treatment: Drug: DLBS2411; Drug: DLBS2411; Drug: Placebo DLBS2411

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta
    • Jakarta Center, Jakarta, Indonesia, 10430
      • Division of Gastroenterology, Department of Internal Medicine, dr. Cipto Mangunkusumo Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Dexa Medica Group
• Investigators: Principal Investigator: Murdani Abdullah, Dr., dr., SpPD-KGEH, Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, University of Indonesia, dr. Cipto Mangunkusumo Hospital, Jakarta Indonesia

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: April 5, 2012
• First Submitted That Met QC Criteria: April 5, 2012
• First Posted (Estimate): April 9, 2012

Study Record Updates

• Last Update Posted (Estimate): February 13, 2013
• Last Update Submitted That Met QC Criteria: February 12, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: gastric pH; DLBS2411; Proton pump inhibitor (PPI)
• Other Study ID Numbers: DLBS2411-0111