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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04888715
Other study ID # DW_DWN12088103
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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