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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-23

Study Completion Date

2021-08-18

Brief Summary

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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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Detailed Description

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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

Conditions

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Idiopathic Pulmonary Fibrosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

DWN12088

Intervention Type DRUG

Prolyl-tRNA synthetase (PRS) inhibitor

Pirfenidone

Intervention Type DRUG

Pirfenidone

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

Group Type EXPERIMENTAL

DWN12088

Intervention Type DRUG

Prolyl-tRNA synthetase (PRS) inhibitor

Nintedanib

Intervention Type DRUG

Nintedanib

Interventions

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DWN12088

Prolyl-tRNA synthetase (PRS) inhibitor

Intervention Type DRUG

Pirfenidone

Intervention Type DRUG

Nintedanib

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes