Back to resultsTo Evaluate Drug-drug Interactions Between DWN12088 and Nebivolol or Paroxetine in Healthy Volunteers
Primary Purpose
Idiopathic Pulmonary Fibrosis
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DWN12088
Nebivolol
Paroxetine
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis
Eligibility Criteria
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
Sites / Locations
- Inje University Busan Paik Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
DWN12088 and Nebivolol
DWN12088 and Paroxetine
Arm Description
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
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
Outcomes
Primary Outcome Measures
Cmax of Nebivolol
Cmax of Nebivolol
AUCt of Nebivolol
AUCt of Nebivolol
Cmax of DWN12088
Cmax of DWN12088
AUCt of DWN12088
AUCt of DWN12088
Secondary Outcome Measures
Full Information
NCT ID
NCT04888728
First Posted
April 28, 2021
Last Updated
August 3, 2021
Sponsor
Daewoong Pharmaceutical Co. LTD.
1. Study Identification
Unique Protocol Identification Number
NCT04888728
Brief Title
To Evaluate Drug-drug Interactions Between DWN12088 and Nebivolol or Paroxetine in Healthy Volunteers
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
June 30, 2021 (Actual)
Primary Completion Date
July 12, 2021 (Actual)
Study Completion Date
July 27, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewoong Pharmaceutical Co. LTD.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
An open label, 2-part, one-sequence, 3-period study to evaluate drug-drug interactions between DWN12088 and nebivolol or Paroxetine in healthy volunteers
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DWN12088 and Nebivolol
Arm Type
Experimental
Arm Description
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
Arm Title
DWN12088 and Paroxetine
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
DWN12088
Intervention Description
Prolyl-tRNA synthetase (PRS) inhibitor
Intervention Type
Drug
Intervention Name(s)
Nebivolol
Intervention Description
Nebivolol
Intervention Type
Drug
Intervention Name(s)
Paroxetine
Intervention Description
Paroxetine
Primary Outcome Measure Information:
Title
Cmax of Nebivolol
Description
Cmax of Nebivolol
Time Frame
Day 1, Day 2, Day 3, Day 6, Day 7, and Day 8
Title
AUCt of Nebivolol
Description
AUCt of Nebivolol
Time Frame
Day 1, Day 2, Day 3, Day 6, Day 7, and Day 8
Title
Cmax of DWN12088
Description
Cmax of DWN12088
Time Frame
Day 1, Day 2, Day 3, Day 4, Day 9, Day 10, Day 11, and Day 12
Title
AUCt of DWN12088
Description
AUCt of DWN12088
Time Frame
Day 1, Day 2, Day 3, Day 4, Day 9, Day 10, Day 11, and Day 12
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong-Lyul Ghim
Organizational Affiliation
Busan Paik Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inje University Busan Paik Hospital
City
Busan
ZIP/Postal Code
47397
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
To Evaluate Drug-drug Interactions Between DWN12088 and Nebivolol or Paroxetine in Healthy Volunteers
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