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

Phase 1

Completed

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: DWN12088; Drug: Pirfenidone; Drug: Nintedanib

• Registration Number: NCT04888715
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

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

Study Timeline

• Study First Submitted: 2021-04-28
• Study First Submitted QC: 2021-05-11
• Study First Posted: 2021-05-17
• Study Start: 2021-07-23
• Primary Completion: 2021-08-02
• Study Completion: 2021-08-18
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-22
• Last Update Posted: 2021-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DWN12088 and Pirfenidone	Pirfenidone	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
DWN12088 and Pirfenidone	DWN12088	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
DWN12088 and Nintedanib	DWN12088	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
DWN12088 and Nintedanib	Nintedanib	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

Primary Outcome Measures

Name	Time	Method
Cmax of Pirfenidone and DWN12088	0hour (pre-dose), 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 10hour, 12hour	Cmax of Pirfenidone and DWN12088
AUC of Pirfenidone and DWN12088	0hour (pre-dose), 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 10hour, 12hour	AUC of Pirfenidone and DWN12088
Cmax of Nintedanib and DWN12088	0hour (pre-dose), 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 10hour, 12hour	Cmax of Nintedanib and DWN12088
AUC of Nintedanib and DWN12088	0hour (pre-dose), 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 10hour, 12hour	AUC of Nintedanib and DWN12088

Trial Locations

Locations (1)

Cha Unitersity Bundang Medical Center; 🇰🇷 Seongnam-si, Korea, Republic of