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

• Sponsor: Daewoong Pharmaceutical Co. LTD. (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT04490434
• Collaborator: (none)
• Enrollment: 110
• Location: 1
• Arms: 6
• Anticipated Duration (Months): 5.4
• Patients Per Site Per Month: 20.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Male Volunteers	Drug: DWP14012; Drug: Celecoxib; Drug: Naproxen; Drug: Meloxicam	Phase 1

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• 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
• Actual Study Start Date: Jun 19, 2020
• Anticipated Primary Completion Date: Aug 31, 2020
• Anticipated Study Completion Date: Nov 30, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. Arm D, 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

8. Arm D, 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

9. 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

10. 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

11. 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

12. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	03080

Sponsors and Collaborators

• Daewoong Pharmaceutical Co. LTD.

Investigators

• Principal Investigator: Jang In-Jin, MD, PhD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daewoong Pharmaceutical Co. LTD.
• ClinicalTrials.gov Identifier: NCT04490434
• Other Study ID Numbers: DW_DWP14012005
• First Posted: Jul 29, 2020
• Last Update Posted: Jul 29, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Celecoxib; Naproxen; Meloxicam

Study Results

No Results Posted as of Jul 29, 2020