Skip to main content
OpenTrials
Completed

NCT Number: NCT02757144

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP14012 After Oral Administration in Healthy Male Volunteers

This is a dose block-randomized, double-blind, placebo- and active-controlled, single and multiple dosing, dose-escalation clinical phase 1 trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of DWP14012 after oral administration in healthy male volunteers.

Completed

Looking for future studies?

Notify Me

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
  • 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 who have been Helicobacter pylori positive
  • Those whose plasma AST (SGOT) and ALT (SGPT) exceed 1.5 times to the upper limit of the normal range in screening including additional examinations prior to randomization
  • Those who have anatomical disability in insertion and maintenance of pH meter catheter

Treatment and study plan

DWP14012

Drug

DWP14012 tablets

Placebo

Drug

DWP14012 placebo-matching tablets, Active control placebo-matching tablets

Esomeprazole

Drug

Nexium®

Primary outcomes

  1. Number and percentage of Participants With Adverse Events (AE)

    Time frame: Day -2(Randomization) to Day 11~18(Post-study visit)

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

  2. Number and percentage of Participants With Adverse Drug Reactions (ADR)

    Time frame: Day -2(Randomization) to Day 11~18(Post-study visit)

    An adverse drug reaction (ADR) is an injury caused by taking an investigational product.

  3. Number of Participants With Clinically Significant Vital Sign findings

    Time frame: Day -2(Randomization) to Day 11~18(Post-study visit)

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

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

    Time frame: Day -2(Randomization) to Day 11~18(Post-study visit)

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

  5. Number of Participants With Clinically Significant Laboratory results

    Time frame: Day -2(Randomization) to Day 11~18(Post-study visit)

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

Secondary outcomes

  1. Cmax: Maximum concentration of DWP14012

    Time frame: 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours

    in single ascending dose cohort

  2. Cmax,ss: Maximum concentration of DWP14012 at steady state

    Time frame: 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24h, Day 3-6 pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours

    in multiple ascending dose cohort

  3. Cmin,ss: Minimum concentration of DWP14012 at steady state

    Time frame: 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24h, Day 3-6 pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours

    in multiple ascending dose cohort

  4. Tmax: Time of maximum concentration

    Time frame: 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours

    in single ascending dose cohort

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

    Time frame: 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24h, Day 3-6 pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours

    in multiple ascending dose cohort

  6. AUClast: Area under the plasma concentration-time curve from time 0 to 48hours

    Time frame: 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours

    in single ascending dose cohort

  7. AUCinf: Area under the plasma concentration-time curve from time 0 to infinity

    Time frame: 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours

    in single ascending dose cohort

  8. AUCtau: Area under the plasma concentration-time curve from time 0 to tau(dosing interval)

    Time frame: 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24h, Day 3-6 pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours

    in multiple ascending dose cohort

  9. T1/2: Elimination half-life

    Time frame: 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours

    in single ascending dose cohort

  10. T1/2: Elimination half-life

    Time frame: 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24h, Day 3-6 pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours

    in multiple ascending dose cohort

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

    Time frame: Day 1

    After single administration of the investigational products, 24hr gastric pH monitoring started.

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

    Time frame: Day 7

    After multiple administration of the investigational products, 24hr gastric pH monitoring started.

  13. Serum gastrin concentration profile

    Time frame: Day -2(Randomization) to Day 11~18(Post-study visit)

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

A Dose Block-randomized, Double-blind, Placebo- and Active-controlled, Single and Multiple Dosing, Dose-escalation Clinical Phase 1 Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP14012 After Oral Administration in Healthy Male Volunteers

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 29, 2016
Registry last updated
Apr 25, 2017

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.