Clinical trial NCT03487562: Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of After Administrations of DWP14012 Alone and Combinations of DWP14012, Clarithromycin and Amoxicillin in Healthy Male Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2018-04-04
Enrollment: 48
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Cmax,ss: Maximum concentration of DWP14012, clarithromycin and metabolite and amoxicillin at steady state
timeFrame: Day 1~7 pre-dose, Day 8 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours
measure: Cmin,ss: Minimum concentration of DWP14012, clarithromycin and metabolite and amoxicillin at steady state
timeFrame: Day 1~7 pre-dose, Day 8 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours
measure: Cav,ss: Average concentration of DWP14012, clarithromycin and metabolite and amoxicillin at steady state
timeFrame: Day 1~7 pre-dose, Day 8 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours
measure: AUCt,ss: Area under the drug concentration-time curve within a dosing interval at steady states
timeFrame: Day 1~7 pre-dose, Day 8 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours
measure: Tmax,ss: Time of maximum concentration at steady state
timeFrame: Day 1~7 pre-dose, Day 8 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours
measure: T1/2: Elimination half-life
timeFrame: Day 1~7 pre-dose, Day 8 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours
measure: Percentage of total time that the intragastric pH was above 4
timeFrame: Period 1 Day -1 and Group A, C Day 7 0~24 hours
measure: Percentage of total time that the intragastric pH was above 4
timeFrame: Day -1, Day 1, Day 7 0~24 hours
measure: Percentage of total time that the intragastric pH was above 6
timeFrame: Period 1 day -1 and Group A, C Day 7 0~24 hours
measure: Percentage of total time that the intragastric pH was above 6
timeFrame: Day -1, Day 1, Day 7 0~24 hours
measure: Serum gastrin concentration profile
timeFrame: Period 1 Day -1 and Group A, C Day 7 pre-dose, 2, 4, 6, 8, 12, 24, 48 hours
measure: Serum gastrin concentration profile
timeFrame: Day -1 pre-dose, 2, 4, 6, 8, 12 hours, Day 1 and 7 pre-dose, 2, 4, 6, 8, 12, 24, 48 hours
measure: Number of participants with Adverse Events (AE)
timeFrame: Day -2 (Randomization) to Day 60 (Post-study visit of Part I) and Day 42 (Follow up visit of Part II)
measure: Number of Participants With Clinically Significant Vital Sign findings
timeFrame: Day -2 (Randomization) to Day 60 (Post-study visit of Part I) and Day 42 (Follow up visit of Part II)
measure: Number of Participants With Clinically Significant Electrocardiogram(12-lead ECG) findings
timeFrame: Day -2 (Randomization) to Day 54~60 (Post-study visit of Part I) and Day 36~42 (Follow up visit of Part II)
measure: Number of Participants With Clinically Significant Laboratory results
timeFrame: Day -2 (Randomization) to Day 60 (Post-study visit of Part I) and Day 42 (Follow up visit of Part II)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: