Clinical trial NCT04490434: Drug-drug Interaction Between DWP14012 and Three Different Kinds of NSAIDs
Official title: A Randomized, Open-label, Multiple-dose Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetic Drug-drug Interaction Between DWP14012 and Three Different Kinds of NSAIDs in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy Male Volunteers
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2020-07-29
Enrollment: 110
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: drug-drug interaction between DWP14012 and three different kinds of NSAIDs

Detailed description: to evaluate the safety/tolerability and pharmacokinetic drug-drug interaction between DWP14012 and three different kinds of NSAIDs in healthy male volunteers

Eligibility criteria: Inclusion Criteria:

* Healthy adult Caucasian or Japanese or Korean aged 19 to 50 (inclusive) years, at the time of screening.
* Subjects weighing between 50 kg and 90 kg with BMI between 18 and 27 kg/m2 (inclusive) at screening visit.

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 1.5 times to the upper limit of the normal range in screening including additional examinations prior to randomization
* Subjects who have participated and taken investigational drug in any other clinical trial (including bioequivalence study) within six months prior to study drug administration
* Subjects who have donated a unit of whole blood within two months or blood components within one month prior to study drug administration

Primary outcomes:
measure: Arm A, Cmax,ss of Celecoxib
timeFrame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
measure: Arm A, AUCτ,ss of Celecoxib
timeFrame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
measure: Arm B, Cmax,ss of DWP14012
timeFrame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
measure: Arm B, AUCτ,ss of DWP14012
timeFrame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
measure: Arm C, Cmax,ss of Naproxen
timeFrame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
measure: Arm C, AUCτ,ss of Naproxen
timeFrame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
measure: Arm D, Cmax,ss of DWP14012
timeFrame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
measure: Arm D, AUCτ,ss of DWP14012
timeFrame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
measure: Arm E, Cmax,ss of Meloxicam
timeFrame: Day 7,(0 hours (pre-dose), 1~72 hours) / Day 16,(0 hours (pre-dose), 1~72 hours)
measure: Arm E, AUCτ,ss of Meloxicam
timeFrame: Day 7,(0 hours (pre-dose), 1~72 hours) / Day 16,(0 hours (pre-dose), 1~72 hours)
measure: Arm D, Cmax,ss of DWP14012
timeFrame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 13,(0 hours (pre-dose), 0.5~48 hours)
measure: Arm D, AUCτ,ss of DWP14012
timeFrame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 13,(0 hours (pre-dose), 0.5~48 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jang In-Jin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: