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

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

drug-drug interaction between DWP14012 and three different kinds of NSAIDs

Study Overview

• Status: Unknown
• Conditions: Healthy Male Volunteers
• Intervention / Treatment: Drug: DWP14012; Drug: Celecoxib; Drug: Naproxen; Drug: Meloxicam

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 Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jang In-Jin, MD, PhD; Phone Number: +82-2-2072-1910; Email: ijjang@snu.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital
    • Contact: In-Jin Jang, MD, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cohort 1, A (DWP14012/Celecoxib); Patients treated with DWP14012, Celecoxib will be enrolled. DDI will be evaluated.	Drug: DWP14012; DWP14012 40mg, bid; Drug: Celecoxib; Celecoxib 200mg, bid
EXPERIMENTAL: Cohort 1, B (DWP14012/Celecoxib); Patients treated with DWP14012, Celecoxib will be enrolled. DDI will be evaluated.	Drug: DWP14012; DWP14012 40mg, bid; Drug: Celecoxib; Celecoxib 200mg, bid
EXPERIMENTAL: Cohort 2, C (DWP14012/Naproxen); Patients treated with DWP14012, Naproxen will be enrolled. DDI will be evaluated.	Drug: DWP14012; DWP14012 40mg, bid; Drug: Naproxen; Naproxen 500mg, bid
EXPERIMENTAL: Cohort 2, D (DWP14012/Naproxen); Patients treated with DWP14012, Naproxen will be enrolled. DDI will be evaluated.	Drug: DWP14012; DWP14012 40mg, bid; Drug: Naproxen; Naproxen 500mg, bid
EXPERIMENTAL: Cohort 3, E (DWP14012/Meloxicam); Patients treated with DWP14012, Meloxicam will be enrolled. DDI will be evaluated.	Drug: DWP14012; DWP14012 40mg, bid; Drug: Meloxicam; Meloxicam 15mg, qd
EXPERIMENTAL: Cohort 3, F (DWP14012/Meloxicam); Patients treated with DWP14012, Meloxicam will be enrolled. DDI will be evaluated.	Drug: DWP14012; DWP14012 40mg, bid; Drug: Meloxicam; Meloxicam 15mg, qd

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.
• Investigators: Principal Investigator: Jang In-Jin, MD, PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 19, 2020
• Primary Completion (ANTICIPATED): August 31, 2020
• Study Completion (ANTICIPATED): November 30, 2020

Study Registration Dates

• First Submitted: April 24, 2020
• First Submitted That Met QC Criteria: July 27, 2020
• First Posted (ACTUAL): July 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Gout Suppressants; Celecoxib; Naproxen; Meloxicam
• Other Study ID Numbers: DW_DWP14012005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No