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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04888728
Recruitment Status : Completed
First Posted : May 17, 2021
Last Update Posted : August 4, 2021
Sponsor:
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.

Tracking Information
First Submitted Date  ICMJE April 28, 2021
First Posted Date  ICMJE May 17, 2021
Last Update Posted Date August 4, 2021
Actual Study Start Date  ICMJE June 30, 2021
Actual Primary Completion Date July 12, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2021)
  • Cmax of Nebivolol [ Time Frame: Day 1, Day 2, Day 3, Day 6, Day 7, and Day 8 ]
    Cmax of Nebivolol
  • AUCt of Nebivolol [ Time Frame: Day 1, Day 2, Day 3, Day 6, Day 7, and Day 8 ]
    AUCt of Nebivolol
  • Cmax of DWN12088 [ Time Frame: Day 1, Day 2, Day 3, Day 4, Day 9, Day 10, Day 11, and Day 12 ]
    Cmax of DWN12088
  • AUCt of DWN12088 [ Time Frame: Day 1, Day 2, Day 3, Day 4, Day 9, Day 10, Day 11, and Day 12 ]
    AUCt of DWN12088
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Evaluate Drug-drug Interactions Between DWN12088 and Nebivolol or Paroxetine in Healthy Volunteers
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Idiopathic Pulmonary Fibrosis
Intervention  ICMJE
  • Drug: DWN12088
    Prolyl-tRNA synthetase (PRS) inhibitor
  • Drug: Nebivolol
    Nebivolol
  • Drug: Paroxetine
    Paroxetine
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: DWN12088
    • Drug: 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
    Interventions:
    • Drug: DWN12088
    • Drug: Paroxetine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 11, 2021)		 24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 27, 2021
Actual Primary Completion Date July 12, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04888728
Other Study ID Numbers  ICMJE DW_DWN12088104
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Daewoong Pharmaceutical Co. LTD.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Daewoong Pharmaceutical Co. LTD.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jong-Lyul Ghim Busan Paik Hospital
PRS Account Daewoong Pharmaceutical Co. LTD.
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP