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

Idiopathic Pulmonary Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04888715
• Other study ID #: DW_DWN12088103
• Status: Completed
• Phase: Phase 1
• Start date: July 23, 2021
• Est. completion date: August 18, 2021

Study information

• Verified date: September 2021
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 18, 2021
• Est. primary completion date: August 2, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• DWN12088
Prolyl-tRNA synthetase (PRS) inhibitor
• Pirfenidone
Pirfenidone
• Nintedanib
Nintedanib

Locations

Country	Name	City	State
Korea, Republic of	Cha Unitersity Bundang Medical Center	Seongnam-si

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