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Completed

NCT Number: NCT04888715

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

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Key information

Conditions

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

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cha Unitersity Bundang Medical Center

Seongnam-si, 13520, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DWN12088

Drug

Prolyl-tRNA synthetase (PRS) inhibitor

pirfenidone

Drug

Pirfenidone

Nintedanib

Drug

Nintedanib

Primary outcomes

  1. Cmax of Pirfenidone and DWN12088

    Time frame: 0hour (pre-dose), 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 10hour, 12hour

    Cmax of Pirfenidone and DWN12088

  2. AUC of Pirfenidone and DWN12088

    Time frame: 0hour (pre-dose), 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 10hour, 12hour

    AUC of Pirfenidone and DWN12088

  3. Cmax of Nintedanib and DWN12088

    Time frame: 0hour (pre-dose), 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 10hour, 12hour

    Cmax of Nintedanib and DWN12088

  4. AUC of Nintedanib and DWN12088

    Time frame: 0hour (pre-dose), 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 10hour, 12hour

    AUC of Nintedanib and DWN12088

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 17, 2021
Registry last updated
Sep 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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