Clinical trial NCT02757144: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP14012 After Oral Administration in Healthy Male Volunteers
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2016-04-29
Enrollment: 120
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 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.


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
* 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

Primary outcomes:
measure: Number and percentage of Participants With Adverse Events (AE)
timeFrame: Day -2(Randomization) to Day 11~18(Post-study visit)
measure: Number and percentage of Participants With Adverse Drug Reactions (ADR)
timeFrame: Day -2(Randomization) to Day 11~18(Post-study visit)
measure: Number of Participants With Clinically Significant Vital Sign findings
timeFrame: Day -2(Randomization) to Day 11~18(Post-study visit)
measure: Number of Participants With Clinically Significant Electrocardiogram(12-lead ECG) findings
timeFrame: Day -2(Randomization) to Day 11~18(Post-study visit)
measure: Number of Participants With Clinically Significant Laboratory results
timeFrame: Day -2(Randomization) to Day 11~18(Post-study visit)
Secondary outcomes:
measure: Cmax: Maximum concentration of DWP14012
timeFrame: 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
measure: Cmax,ss: Maximum concentration of DWP14012 at steady state
timeFrame: 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
measure: Cmin,ss: Minimum concentration of DWP14012 at steady state
timeFrame: 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
measure: Tmax: Time of maximum concentration
timeFrame: 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
measure: Tmax,ss: Time of maximum concentration at steady state
timeFrame: 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
measure: AUClast: Area under the plasma concentration-time curve from time 0 to 48hours
timeFrame: 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
measure: AUCinf: Area under the plasma concentration-time curve from time 0 to infinity
timeFrame: 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
measure: AUCtau: Area under the plasma concentration-time curve from time 0 to tau(dosing interval)
timeFrame: 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
measure: T1/2: Elimination half-life
timeFrame: 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
measure: T1/2: Elimination half-life
timeFrame: 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
measure: Percentage of total time that the intragastric pH was above 4
timeFrame: Day 1
measure: Percentage of total time that the intragastric pH was above 4
timeFrame: Day 7
measure: Serum gastrin concentration profile
timeFrame: Day -2(Randomization) to Day 11~18(Post-study visit)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: