Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04328766




Registration number
NCT04328766
Ethics application status
Date submitted
24/03/2020
Date registered
31/03/2020
Date last updated
16/08/2021

Titles & IDs
Public title
Pharmacokinetic Interaction Between DWP14012 and DWC202005 in Healthy Volunteers
Scientific title
An Open-Label, Multiple-Dose Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetic Interaction Between DWP14012 and DWC202005 in Healthy Volunteers
Secondary ID [1] 0 0
DW_DWP14012106
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Drug-drug Interaction 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - DWC202005, alone
Treatment: Drugs - DWP14012 + DWC202005
Treatment: Drugs - DWP14012 + DWC202005, after multiple doses of DWP14012

Experimental: DWP14012 Cohort A -

Experimental: DWP14012 Cohort B -

Experimental: DWP14012 Cohort C -


Treatment: Drugs: DWC202005, alone
DWC202005, as a single dose

Treatment: Drugs: DWP14012 + DWC202005
DWP14012 and DWC202005, as a single dose

Treatment: Drugs: DWP14012 + DWC202005, after multiple doses of DWP14012
DWP14012 and DWC202005, after multiple oral doses of DWP14012 once daily for 12 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Area under the plasma drug concentration-time curve
Timepoint [1] 0 0
upto 48 hours postdose
Primary outcome [2] 0 0
Peak Plasma Concentration (Cmax)
Timepoint [2] 0 0
upto 48 hours postdose
Primary outcome [3] 0 0
Incidence of Treatment-Emergent Adverse Events
Timepoint [3] 0 0
up to 19 days

Eligibility
Key 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
Minimum age
19 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/09/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/11/2020
Sample size
Target
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Nucleus Network (QPharm) - Queensland
Recruitment postcode(s) [1] 0 0
78 - Queensland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Daewoong Pharmaceutical Co. LTD.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
An open-label, multiple-dose clinical trial to evaluate the safety/tolerability and
pharmacokinetic interaction between DWP14012 and DWC202005 in healthy volunteers
Trial website
https://clinicaltrials.gov/ct2/show/NCT04328766
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04328766