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

Healthy Male Volunteers Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04490434
• Other study ID #: DW_DWP14012005
• Status: Recruiting
• Phase: Phase 1
• Start date: June 19, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: July 2020
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: Jang In-Jin, MD, PhD
• Phone: +82-2-2072-1910
• Email: ijjang[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: November 30, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Male Volunteers

Intervention

Drug:
• DWP14012
DWP14012 40mg, bid
• Celecoxib
Celecoxib 200mg, bid
• Naproxen
Naproxen 500mg, bid
• Meloxicam
Meloxicam 15mg, qd

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Arm A, AUCt,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)
Primary	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)
Primary	Arm B, AUCt,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)
Primary	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)
Primary	Arm C, AUCt,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)
Primary	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)
Primary	Arm D, AUCt,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)
Primary	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)
Primary	Arm E, AUCt,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)
Primary	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)
Primary	Arm D, AUCt,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)