Pharmacokinetic Interaction Between DWP14012 and DWC202005 in Healthy Volunteers

NCT04328766 — Phase 1, Completed, 36 participants, Daewoong Pharmaceutical Co. LTD.

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An Open-Label, Multiple-Dose Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetic Interaction Between DWP14012 and DWC202005 in Healthy Volunteers

Registry	NCT04328766
Status	Completed
Phase	Phase 1
Study type	Interventional; non randomized, parallel, masking: none, treatment
Enrollment	36 (Actual)
Sponsor	Daewoong Pharmaceutical Co. LTD. (Industry)
Conditions	Drug-drug Interaction
Interventions	DWC202005, alone, DWP14012 + DWC202005, DWP14012 + DWC202005, after multiple doses of DWP14012 (Drug)
Dates	start 2020-09-06, primary completion 2020-11-21, completion 2020-11-21, first posted 2020-03-31, last updated 2021-08-16
Locations	1 site in Australia

-Summary

An open-label, multiple-dose clinical trial to evaluate the safety/tolerability and pharmacokinetic interaction between DWP14012 and DWC202005 in healthy volunteers

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+Arms and interventions

Arm	Type	Interventions
DWP14012 Cohort A	Experimental	Drug: DWC202005, alone
DWP14012 Cohort B	Experimental	Drug: DWP14012 + DWC202005
DWP14012 Cohort C	Experimental	Drug: DWP14012 + DWC202005, after multiple doses of DWP14012

DWC202005, alone (Drug): DWC202005, as a single dose
DWP14012 + DWC202005 (Drug): DWP14012 and DWC202005, as a single dose
DWP14012 + DWC202005, after multiple doses of DWP14012 (Drug): DWP14012 and DWC202005, after multiple oral doses of DWP14012 once daily for 12 days

+Outcome measures

Primary outcomes

Area under the plasma drug concentration-time curve [upto 48 hours postdose]: AUClast of DWC202005
Peak Plasma Concentration (Cmax) [upto 48 hours postdose]: Cmax of DWC202005
Incidence of Treatment-Emergent Adverse Events [up to 19 days]

+Eligibility

Sex: All, ages: 19 Years to 50 Years, accepts healthy volunteers

Inclusion Criteria:

* Healthy adults aged 19 to 50 years with BMI between 18.5 kg/m2 and 30.0 kg/m2
* Capable of understanding provided information and complying with protocol requirements
* Provide written informed consent to participate in the study

+Locations (1)

Facility	City	Country	Status
Nucleus Network (QPharm)	Queensland, Queensland	Australia