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

• Sponsor: Daewoong Pharmaceutical Co. LTD. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04888715
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 2
• Actual Duration (Days): 26
• Patients Per Site Per Month: 56.2

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Pulmonary Fibrosis	Drug: DWN12088; Drug: Pirfenidone; Drug: Nintedanib	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jul 23, 2021
• Actual Primary Completion Date: Aug 2, 2021
• Actual Study Completion Date: Aug 18, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DWN12088 and 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	Drug: DWN12088; Prolyl-tRNA synthetase (PRS) inhibitor; Drug: Pirfenidone; Pirfenidone
Experimental: DWN12088 and 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	Drug: DWN12088; Prolyl-tRNA synthetase (PRS) inhibitor; Drug: Nintedanib; Nintedanib

Outcome Measures

Primary Outcome Measures

1. Cmax of Pirfenidone and DWN12088 [0hour (pre-dose), 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 10hour, 12hour]

   Cmax of Pirfenidone and DWN12088

2. AUC of Pirfenidone and DWN12088 [0hour (pre-dose), 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 10hour, 12hour]

   AUC of Pirfenidone and DWN12088

3. Cmax of Nintedanib and DWN12088 [0hour (pre-dose), 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 10hour, 12hour]

   Cmax of Nintedanib and DWN12088

4. AUC of Nintedanib and DWN12088 [0hour (pre-dose), 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 10hour, 12hour]

   AUC of Nintedanib and DWN12088

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cha Unitersity Bundang Medical Center	Seongnam-si		Korea, Republic of	13520

Sponsors and Collaborators

• Daewoong Pharmaceutical Co. LTD.

Investigators

• Principal Investigator: Kim, CHA UNITERSITY BUNDANG MEDICAL CENTER

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daewoong Pharmaceutical Co. LTD.
• ClinicalTrials.gov Identifier: NCT04888715
• Other Study ID Numbers: DW_DWN12088103
• First Posted: May 17, 2021
• Last Update Posted: Sep 23, 2021
• Last Verified: Sep 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Pirfenidone; Nintedanib

Study Results

No Results Posted as of Sep 23, 2021