Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP14012 After Oral Administration in Healthy Male Volunteers
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
1 other identifier
interventional
120
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Mar 2016
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 16, 2016
CompletedFirst Posted
Study publicly available on registry
April 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedApril 25, 2017
April 1, 2017
11 months
March 16, 2016
April 23, 2017
Conditions
Outcome Measures
Primary Outcomes (5)
Number and percentage of Participants With Adverse Events (AE)
All AE standardized using MedDRA was assessed by investigator using the protocol defined grading system. Intensity was categorized as mild, moderate adn severe.
Day -2(Randomization) to Day 11~18(Post-study visit)
Number and percentage of Participants With Adverse Drug Reactions (ADR)
An adverse drug reaction (ADR) is an injury caused by taking an investigational product.
Day -2(Randomization) to Day 11~18(Post-study visit)
Number of Participants With Clinically Significant Vital Sign findings
Blood pressure, pulse and body temperature were tested. The Average, Median, Standard Deviation, Min, Max values will be calculated to assess the safety/tolerability.
Day -2(Randomization) to Day 11~18(Post-study visit)
Number of Participants With Clinically Significant Electrocardiogram(12-lead ECG) findings
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).
Day -2(Randomization) to Day 11~18(Post-study visit)
Number of Participants With Clinically Significant Laboratory results
Hematology, Blood chemistry, Coagulation and Urinalysis were tested. The Average, Median, Standard Deviation, Min, Max values will be calculated to assess the safety/tolerability.
Day -2(Randomization) to Day 11~18(Post-study visit)
Secondary Outcomes (13)
Cmax: Maximum concentration of DWP14012
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
Cmax,ss: Maximum concentration of DWP14012 at steady state
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
Cmin,ss: Minimum concentration of DWP14012 at steady state
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
Tmax: Time of maximum concentration
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
Tmax,ss: Time of maximum concentration at steady state
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
- +8 more secondary outcomes
Study Arms (14)
Cohort 1: DWP14012 Amg
EXPERIMENTALDWP14012 Amg, tablets, orally, single dose administration
Cohort 2: DWP14012 Bmg
EXPERIMENTALDWP14012 Bmg, tablets, orally, single dose administration
Cohort 3: DWP14012 Cmg
EXPERIMENTALDWP14012 Cmg, tablets, orally, single dose administration
Cohort 4: DWP14012 Dmg
EXPERIMENTALDWP14012 Dmg, tablets, orally, single dose administration
Cohort 5: DWP14012 Emg
EXPERIMENTALDWP14012 Emg, tablets, orally, single dose administration
Cohort 6: DWP14012 Fmg
EXPERIMENTALDWP14012 Emg, tablets, orally, single dose administration
Cohort 1-6: Placebo
PLACEBO COMPARATORDWP14012 placebo-matching tablets, Active-control placebo-matching tablets, orally, single dose administration
Cohort 1-6: Esomeprazole
ACTIVE COMPARATORNexium® tablets, orally, single dose administration
Cohort 7: DWP14012 Amg
EXPERIMENTALDWP14012 Amg, tablets, orally, repeated dose administration(for 7days)
Cohort 8: DWP14012 Bmg
EXPERIMENTALDWP14012 Bmg, tablets, orally, repeated dose administration(for 7days)
Cohort 9: DWP14012 Cmg
EXPERIMENTALDWP14012 Cmg, tablets, orally, repeated dose administration(for 7days)
Cohort 7-10: Placebo
PLACEBO COMPARATORDWP14012 placebo-matching tablets, Active-control placebo-matching tablets, orally, repeated dose administration(for 7days)
Cohort 7-10: Esomeprazole
ACTIVE COMPARATORNexium®, orally, repeated dose administration(for 7days)
Cohort 9: DWP14012 Dmg
EXPERIMENTALDWP14012 Dmg, tablets, orally, repeated dose administration(for 7days)
Interventions
DWP14012 tablets
DWP14012 placebo-matching tablets, Active control placebo-matching tablets
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2016
First Posted
April 29, 2016
Study Start
March 1, 2016
Primary Completion
February 1, 2017
Study Completion
February 1, 2017
Last Updated
April 25, 2017
Record last verified: 2017-04