To Evaluate Drug-drug Interactions Between DWN12088 and Nebivolol or Paroxetine in Healthy Volunteers

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

An open label, 2-part, one-sequence, 3-period study to evaluate drug-drug interactions between DWN12088 and nebivolol or Paroxetine in healthy volunteers

Study Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Drug: DWN12088; Drug: Nebivolol; Drug: Paroxetine

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 47397
    • Inje University Busan Paik Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy male adults aged ≥ 20 and ≤ 55 years at screening
• Subjects who voluntarily decided to participate in the study and provided written consent to follow study compliance requirements after receiving a detailed explanation on this study and fully understanding the information

Exclusion Criteria:

• Subjects unable to have the standard meal provided at the study site
• Subjects who took (the day of taking the last dose) another investigational or bioequivalence study product within 180 days prior to the first dose

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 Nebivolol; Period 1 - Nebivolol A mg, Tablet, oral, once daily, Period 2 - DWN12088 X mg, Tablet, oral, twice daily, Period 3 - 1) Nebivolol A mg, Tablet, oral, once daily & DWN12088 X mg, Tablet, oral, twice daily, 2) DWN12088 X mg, Tablet, oral, once daily	Drug: DWN12088; Prolyl-tRNA synthetase (PRS) inhibitor; Drug: Nebivolol; Nebivolol
Experimental: DWN12088 and Paroxetine; Period 1 - DWN12088 X mg, Tablet, oral, once daily , Period 2 - Paroxetine B mg, Tablet, oral, once daily, Period 3 - 1) DWN12088 X mg, Tablet, oral, once daily & Paroxetine B mg, Tablet, oral, once daily, 2) Paroxetine B mg, Tablet, oral, once daily	Drug: DWN12088; Prolyl-tRNA synthetase (PRS) inhibitor; Drug: Paroxetine; Paroxetine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax of Nebivolol	Cmax of Nebivolol	Day 1, Day 2, Day 3, Day 6, Day 7, and Day 8
AUCt of Nebivolol	AUCt of Nebivolol	Day 1, Day 2, Day 3, Day 6, Day 7, and Day 8
Cmax of DWN12088	Cmax of DWN12088	Day 1, Day 2, Day 3, Day 4, Day 9, Day 10, Day 11, and Day 12
AUCt of DWN12088	AUCt of DWN12088	Day 1, Day 2, Day 3, Day 4, Day 9, Day 10, Day 11, and Day 12

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.
• Investigators: Principal Investigator: Jong-Lyul Ghim, Busan Paik Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2021
• Primary Completion (Actual): July 12, 2021
• Study Completion (Actual): July 27, 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): August 4, 2021
• Last Update Submitted That Met QC Criteria: August 3, 2021
• Last Verified: August 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; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Enzyme Inhibitors; Adrenergic Agonists; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Adrenergic beta-Agonists; Adrenergic beta-1 Receptor Agonists; Paroxetine; Nebivolol
• Other Study ID Numbers: DW_DWN12088104

Drug and device information, study documents

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