Efficacy and Safety of DLBS2411 in Healthy Volunteers

Dexa Medica

Status and phase: Completed; Phase 2; Phase 1

Conditions: Gastric pH Regulation in Healthy Volunteers

Treatments: Drug: DLBS2411; Drug: Placebo DLBS2411

Study type: Interventional

Funder types: Industry

Identifiers

NCT01573403

DLBS2411-0111

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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54 participants in 3 patient groups, including a placebo group

Treatment 1

Experimental group

Description:

one dose of DLBS2411 @250 mg

Treatment:

Drug: DLBS2411

Drug: DLBS2411

Treatment II

Experimental group

Description:

two doses of DLBS2411 @250 mg

Treatment:

Drug: DLBS2411

Drug: DLBS2411

Treatment III

Placebo Comparator group

Treatment:

Drug: Placebo DLBS2411