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

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

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 Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Drug: Nintedanib; Drug: DWN12088; Drug: Pirfenidone

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seongnam-si, Korea, Republic of, 13520
    • Cha Unitersity Bundang Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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: Nintedanib; Nintedanib; Drug: DWN12088; Prolyl-tRNA synthetase (PRS) inhibitor

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.
• Investigators: Principal Investigator: Kim, Cha Unitersity Bundang Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2021
• Primary Completion (Actual): August 2, 2021
• Study Completion (Actual): August 18, 2021

Study Registration Dates

• First Submitted: April 28, 2021
• First Submitted That Met QC Criteria: May 11, 2021
• First Posted (Actual): May 17, 2021

Study Record Updates

• Last Update Posted (Actual): September 23, 2021
• Last Update Submitted That Met QC Criteria: September 22, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Protein Kinase Inhibitors; Pirfenidone; Nintedanib
• Other Study ID Numbers: DW_DWN12088103

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No