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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	20 Years - 55 Years
Gender	Male

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04888728
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Daewoong Pharmaceutical Co. LTD.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jong-Lyul Ghim
Principal Investigator Affiliation	Busan Paik Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Korea, Republic of
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Idiopathic Pulmonary Fibrosis

Arms & Interventions

Arms

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

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

Prolyl-tRNA synthetase (PRS) inhibitor

Drug: - Nebivolol

Nebivolol

Drug: - Paroxetine

Paroxetine

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.