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Completed

NCT Number: NCT03487562

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

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

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Key information

Conditions

Healthy

Age range

19 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DWP14012 Amg

Drug

DWP14012 Amg

DWP14012 Bmg

Drug

DWP14012 Bmg

Clarithromycin

Drug

Clarithromycin 500 mg

Amoxicillin

Drug

Amoxicillin 1 g

Lansoprazole

Drug

Lansoprazole 30 mg

Primary outcomes

  1. Cmax,ss: Maximum concentration of DWP14012, clarithromycin and metabolite and amoxicillin at steady state

    Time frame: 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

    Part I: each period (Group A, B, C, D) Part II: Group A, B

  2. Cmin,ss: Minimum concentration of DWP14012, clarithromycin and metabolite and amoxicillin at steady state

    Time frame: 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

    Part I: each period (Group A, B, C, D) Part II: Group A, B

  3. Cav,ss: Average concentration of DWP14012, clarithromycin and metabolite and amoxicillin at steady state

    Time frame: 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

    Part I: each period (Group A, B, C, D) Part II: Group A, B

  4. AUCt,ss: Area under the drug concentration-time curve within a dosing interval at steady states

    Time frame: 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

    Part I: each period (Group A, B, C, D) Part II: Group A, B

  5. Tmax,ss: Time of maximum concentration at steady state

    Time frame: 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

    Part I: each period (Group A, B, C, D) Part II: Group A, B

  6. T1/2: Elimination half-life

    Time frame: 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

    Part I: each period (Group A, B, C, D) Part II: Group A, B

  7. Percentage of total time that the intragastric pH was above 4

    Time frame: Period 1 Day -1 and Group A, C Day 7 0~24 hours

    Part I

  8. Percentage of total time that the intragastric pH was above 4

    Time frame: Day -1, Day 1, Day 7 0~24 hours

    Part II

  9. Percentage of total time that the intragastric pH was above 6

    Time frame: Period 1 day -1 and Group A, C Day 7 0~24 hours

    Part I

  10. Percentage of total time that the intragastric pH was above 6

    Time frame: Day -1, Day 1, Day 7 0~24 hours

    Part II

  11. Serum gastrin concentration profile

    Time frame: Period 1 Day -1 and Group A, C Day 7 pre-dose, 2, 4, 6, 8, 12, 24, 48 hours

    Part I

  12. Serum gastrin concentration profile

    Time frame: Day -1 pre-dose, 2, 4, 6, 8, 12 hours, Day 1 and 7 pre-dose, 2, 4, 6, 8, 12, 24, 48 hours

    Part II

  13. Number of participants with Adverse Events (AE)

    Time frame: Day -2 (Randomization) to Day 60 (Post-study visit of Part I) and Day 42 (Follow up visit of Part II)

    All AE standardized using MedDRA was assessed by investigator using the protocol defined grading system. Intensity was categorized as mild, moderate and severe

  14. Number of Participants With Clinically Significant Vital Sign findings

    Time frame: Day -2 (Randomization) to Day 60 (Post-study visit of Part I) and Day 42 (Follow up visit of Part II)

    Blood pressure(mmHg), pulse (beats/min) and body temperature(℃) were tested. The Average, Median, Standard Deviation, Min, Max values will be calculated to assess the safety/tolerability.

  15. Number of Participants With Clinically Significant Electrocardiogram(12-lead ECG) findings

    Time frame: Day -2 (Randomization) to Day 54~60 (Post-study visit of Part I) and Day 36~42 (Follow up visit of Part II)

    Ventricular rate(beats/min), RR, PR interval(msec), QRS duration(msec), QTcB and QTcF were recorded. The results of 12-lead ECG will be categorized Normal/Abnormal NCS(No clinically significant)/Abnormal CS(clinically significant).

  16. Number of Participants With Clinically Significant Laboratory results

    Time frame: Day -2 (Randomization) to Day 60 (Post-study visit of Part I) and Day 42 (Follow up visit of Part II)

    Hematology, Blood chemistry, Coagulation and Urinalysis were tested. The Average, Median, Standard Deviation, Min, Max values will be calculated to assess the safety/tolerability.

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 4, 2018
Registry last updated
Jun 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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