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

NCT04888715 | Completed Phase 1

• 1 other identifier: DW_DWN12088103
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

DWN12088 and Pirfenidone

EXPERIMENTAL

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; Drug: Pirfenidone

DWN12088 and Nintedanib

EXPERIMENTAL

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; Drug: Nintedanib

Interventions

DWN12088 DRUG

Prolyl-tRNA synthetase (PRS) inhibitor

DWN12088 and Nintedanib; DWN12088 and Pirfenidone

Pirfenidone DRUG

Pirfenidone

DWN12088 and Pirfenidone

Nintedanib DRUG

Nintedanib

DWN12088 and Nintedanib

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

Cha Unitersity Bundang Medical Center

Seongnam-si, 13520, South Korea

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

pirfenidone; nintedanib

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Kim

  CHA UNITERSITY BUNDANG MEDICAL CENTER

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 17, 2021
• Study Start: July 23, 2021
• Primary Completion: August 2, 2021
• Study Completion: August 18, 2021
• Last Updated: September 23, 2021

Record last verified: 2021-09

Locations

KR (1)