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To Evaluate Drug-drug Interactions Between DWN12088 and Pirfenidone or Nintedanib in Healthy Volunteers

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

DWN12088

Pirfenidone

Nintedanib

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis

Eligibility Criteria

19 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy adults aged ≥ 19 and ≤ 55 years at screening
Subjects who voluntarily decided to participate in the study and provided written consent to after receiving a detailed explanation on this study and fully understanding the information

Exclusion Criteria:

Subjects who received another investigational agent in another study (including bioequivalence study) within 180 days prior to the first dose of the IP (The end of prior study participation will be the date of the last dose, and the days will be counted from the next day [1 day].)
Female subjects who are pregnant or lactating

Sites / Locations

Cha Unitersity Bundang Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

DWN12088 and Pirfenidone

DWN12088 and Nintedanib

Arm Description

T1 - Pirfenidone A mg, Tablet, oral, once daily, T2 - 1) DWN12088 X mg, Tablet, oral, once daily, 2) DWN12088 X mg, Tablet, oral, twice daily, T3 - DWN12088 X mg, Tablet, oral, once daily+ Pirfenidone A mg, Tablet, oral, once daily

T1 - Nintedanib B mg, Tablet, oral, once daily, T2 - DWN12088 X mg, Tablet, oral, twice daily, T3 - DWN12088 X mg, Tablet, oral, once daily+ Nintedanib B mg, Tablet, oral, once daily

Outcomes

Primary Outcome Measures

Cmax of Pirfenidone and DWN12088

AUC of Pirfenidone and DWN12088

Cmax of Nintedanib and DWN12088

AUC of Nintedanib and DWN12088

Secondary Outcome Measures

Full Information

NCT ID

NCT04888715

First Posted

April 28, 2021

Last Updated

September 22, 2021

Sponsor

Daewoong Pharmaceutical Co. LTD.

1. Study Identification

Unique Protocol Identification Number

NCT04888715

Brief Title

To Evaluate Drug-drug Interactions Between DWN12088 and Pirfenidone or Nintedanib in Healthy Volunteers

Official Title

An Open Label, 2-part, One-sequence, 3-period Study to Evaluate Drug-drug Interactions Between "DWN12088" and "Pirfenidone" or "Nintedanib" in Healthy Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

July 23, 2021 (Actual)

Primary Completion Date

August 2, 2021 (Actual)

Study Completion Date

August 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Daewoong Pharmaceutical Co. LTD.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

An open label, 2-part, one-sequence, 3-period study to evaluate drug-drug interactions between DWN12088 and Pirfenidone or Nintedanib in healthy volunteers

Detailed Description

This clinical trial is an open label, 2-part, one-sequence, 3-period study to evaluate drug-drug interactions between DWN12088 and Pirfenidone or Nintedanib in healthy volunteers

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Idiopathic Pulmonary Fibrosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DWN12088 and Pirfenidone

Arm Type

Experimental

Arm Description

Arm Title

DWN12088 and Nintedanib

Arm Type

Experimental

Arm Description

T1 - Nintedanib B mg, Tablet, oral, once daily, T2 - DWN12088 X mg, Tablet, oral, twice daily, T3 - DWN12088 X mg, Tablet, oral, once daily+ Nintedanib B mg, Tablet, oral, once daily

Intervention Type

Drug

Intervention Name(s)

DWN12088

Intervention Description

Prolyl-tRNA synthetase (PRS) inhibitor

Intervention Type

Drug

Intervention Name(s)

Pirfenidone

Intervention Description

Pirfenidone

Intervention Type

Drug

Intervention Name(s)

Nintedanib

Intervention Description

Nintedanib

Primary Outcome Measure Information:

Title

Cmax of Pirfenidone and DWN12088

Description

Cmax of Pirfenidone and DWN12088

Time Frame

0hour (pre-dose), 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 10hour, 12hour

Title

AUC of Pirfenidone and DWN12088

Description

AUC of Pirfenidone and DWN12088

Time Frame

0hour (pre-dose), 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 10hour, 12hour

Title

Cmax of Nintedanib and DWN12088

Description

Cmax of Nintedanib and DWN12088

Time Frame

0hour (pre-dose), 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 10hour, 12hour

Title

AUC of Nintedanib and DWN12088

Description

AUC of Nintedanib and DWN12088

Time Frame

0hour (pre-dose), 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 10hour, 12hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy adults aged ≥ 19 and ≤ 55 years at screening Subjects who voluntarily decided to participate in the study and provided written consent to after receiving a detailed explanation on this study and fully understanding the information Exclusion Criteria: Subjects who received another investigational agent in another study (including bioequivalence study) within 180 days prior to the first dose of the IP (The end of prior study participation will be the date of the last dose, and the days will be counted from the next day [1 day].) Female subjects who are pregnant or lactating

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kim

Organizational Affiliation

CHA UNITERSITY BUNDANG MEDICAL CENTER

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cha Unitersity Bundang Medical Center

City

Seongnam-si

ZIP/Postal Code

13520

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

To Evaluate Drug-drug Interactions Between DWN12088 and Pirfenidone or Nintedanib in Healthy Volunteers

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