Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of After Administrations of DWP14012 Alone and Combinations of DWP14012, Clarithromycin and Amoxicillin in Healthy Male Subjects

Daewoong Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Amoxicillin; Drug: Clarithromycin; Drug: Lansoprazole; Drug: DWP14012 Amg; Drug: DWP14012 Bmg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03487562

DW_DWP14012003

Details and patient eligibility

About

This is a randomized, open-label, multiple dose, two-part phase I clinical trial to compare the pharmacokinetics, pharmacodynamics and safety/tolerability of DWP14012 after administrations of DWP14012 alone and combinations of DWP14012, Clarithromycin and Amoxicillin in healthy male subjects

Enrollment: 48 patients

Sex: Male

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adult males aged between 19 and 50 at screening
• Those whose weight is between 55 and 90 kg and BMI is between 18.0 and 27.0
• Part I: Those who have been helicobacter pylori negative at screening Part II: Those who have been helicobacter pylori positive at screening
• Those who are adequate to be subjects in this study upon judgment of the investigator after physical examination, clinical laboratory test, examination by interview, etc

Exclusion criteria

• Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history
• Those who have gastrointestinal diseases or past history of gastrointestinal diseases (gastrointestinal ulcer, gastritis, gastrospasm, gastroesophageal reflux, Crohn's disease etc.) that may affect safety and pharmacokinetic/pharmacodynamic evaluation of study drug, and those who have past history of gastrointestinal surgery (however, except simple appendectomy and herniotomy)
• Those whose plasma AST (SGOT) and ALT (SGPT) exceed to the upper limit of the normal range
• Those who have anatomical disability in insertion and maintenance of pH meter catheter

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 7 patient groups

Sequence 1

Experimental group

Description:

Part I: A-B-D-C A: DWP14012 A mg bid B: DWP14012 A mg bid + Clarithromycin 500 mg bid C: DWP14012 A mg bid + Clarithromycin 500 mg bid + Amoxicillin 1 g bid D: Clarithromycin 500 mg bid + Amoxicillin 1 g bid

Treatment:

Drug: DWP14012 Amg

Drug: Clarithromycin

Drug: Amoxicillin

Sequence 2

Experimental group

Description:

Part I: B-C-A-D A: DWP14012 A mg bid B: DWP14012 A mg bid + Clarithromycin 500 mg bid C: DWP14012 A mg bid + Clarithromycin 500 mg bid + Amoxicillin 1 g bid D: Clarithromycin 500 mg bid + Amoxicillin 1 g bid

Treatment:

Drug: DWP14012 Amg

Drug: Clarithromycin

Drug: Amoxicillin

Sequence 3

Experimental group

Description:

Part I: C-D-B-A A: DWP14012 A mg bid B: DWP14012 A mg bid + Clarithromycin 500 mg bid C: DWP14012 A mg bid + Clarithromycin 500 mg bid + Amoxicillin 1 g bid D: Clarithromycin 500 mg bid + Amoxicillin 1 g bid

Treatment:

Drug: DWP14012 Amg

Drug: Clarithromycin

Drug: Amoxicillin

Sequence 4

Experimental group

Description:

Part I: D-A-C-B A: DWP14012 A mg bid B: DWP14012 A mg bid + Clarithromycin 500 mg bid C: DWP14012 A mg bid + Clarithromycin 500 mg bid + Amoxicillin 1 g bid D: Clarithromycin 500 mg bid + Amoxicillin 1 g bid

Treatment:

Drug: DWP14012 Amg

Drug: Clarithromycin

Drug: Amoxicillin

A

Experimental group

Description:

Part II: (DWP14012 B mg + Clarithromycin 500 mg + Amoxicillin 1g) bid

Treatment:

Drug: DWP14012 Bmg

Drug: Clarithromycin

Drug: Amoxicillin

B

Experimental group

Description:

Part II: (DWP14012 A mg + Clarithromycin 500 mg + Amoxicillin 1g) bid

Treatment:

Drug: DWP14012 Amg

Drug: Clarithromycin

Drug: Amoxicillin

C

Experimental group

Description:

Part II: (Lansoprazole 30 mg + Clarithromycin 500 mg + Amoxicillin 1g) bid

Treatment:

Drug: Lansoprazole

Drug: Clarithromycin

Drug: Amoxicillin