Drug-drug Interaction Between DWP14012 and Three Different Kinds of NSAIDs

Phase 1

• Conditions: Healthy Male Volunteers
• Interventions: Drug: DWP14012; Drug: Celecoxib; Drug: Naproxen; Drug: Meloxicam

• Registration Number: NCT04490434
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

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

Study Timeline

• Study First Submitted: 2020-04-24
• Study Start: 2020-06-19
• Status Verified: 2020-07
• Study First Submitted QC: 2020-07-27
• Last Update Submitted: 2020-07-27
• Study First Posted: 2020-07-29
• Last Update Posted: 2020-07-29
• Primary Completion: 2020-08-31
• Study Completion: 2020-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cohort 3, E (DWP14012/Meloxicam)	DWP14012	Patients treated with DWP14012, Meloxicam will be enrolled. DDI will be evaluated.
Cohort 2, D (DWP14012/Naproxen)	DWP14012	Patients treated with DWP14012, Naproxen will be enrolled. DDI will be evaluated.
Cohort 1, A (DWP14012/Celecoxib)	DWP14012	Patients treated with DWP14012, Celecoxib will be enrolled. DDI will be evaluated.
Cohort 2, C (DWP14012/Naproxen)	DWP14012	Patients treated with DWP14012, Naproxen will be enrolled. DDI will be evaluated.
Cohort 3, F (DWP14012/Meloxicam)	DWP14012	Patients treated with DWP14012, Meloxicam will be enrolled. DDI will be evaluated.
Cohort 1, B (DWP14012/Celecoxib)	DWP14012	Patients treated with DWP14012, Celecoxib will be enrolled. DDI will be evaluated.
Cohort 1, A (DWP14012/Celecoxib)	Celecoxib	Patients treated with DWP14012, Celecoxib will be enrolled. DDI will be evaluated.
Cohort 1, B (DWP14012/Celecoxib)	Celecoxib	Patients treated with DWP14012, Celecoxib will be enrolled. DDI will be evaluated.
Cohort 2, C (DWP14012/Naproxen)	Naproxen	Patients treated with DWP14012, Naproxen will be enrolled. DDI will be evaluated.
Cohort 3, E (DWP14012/Meloxicam)	Meloxicam	Patients treated with DWP14012, Meloxicam will be enrolled. DDI will be evaluated.
Cohort 2, D (DWP14012/Naproxen)	Naproxen	Patients treated with DWP14012, Naproxen will be enrolled. DDI will be evaluated.
Cohort 3, F (DWP14012/Meloxicam)	Meloxicam	Patients treated with DWP14012, Meloxicam will be enrolled. DDI will be evaluated.

Primary Outcome Measures

Name	Time	Method
Arm A, Cmax,ss of Celecoxib	Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)	Maximum measured plasma concentration at steady-state
Arm A, AUCτ,ss of Celecoxib	Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)	Area under the plasma concentration-time curve
Arm B, Cmax,ss of DWP14012	Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)	Maximum measured plasma concentration at steady-state
Arm B, AUCτ,ss of DWP14012	Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)	Area under the plasma concentration-time curve
Arm C, Cmax,ss of Naproxen	Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)	Maximum measured plasma concentration at steady-state
Arm C, AUCτ,ss of Naproxen	Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)	Area under the plasma concentration-time curve
Arm D, Cmax,ss of DWP14012	Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 13,(0 hours (pre-dose), 0.5~48 hours)	Maximum measured plasma concentration at steady-state
Arm D, AUCτ,ss of DWP14012	Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 13,(0 hours (pre-dose), 0.5~48 hours)	Area under the plasma concentration-time curve
Arm E, Cmax,ss of Meloxicam	Day 7,(0 hours (pre-dose), 1~72 hours) / Day 16,(0 hours (pre-dose), 1~72 hours)	Maximum measured plasma concentration at steady-state
Arm E, AUCτ,ss of Meloxicam	Day 7,(0 hours (pre-dose), 1~72 hours) / Day 16,(0 hours (pre-dose), 1~72 hours)	Area under the plasma concentration-time curve

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of