Clinical trial NCT05812404: Phase 1 Clinical Trial to Evaluate the Effect of DWP14012 on the Pharmacokinetics of DWC202201 in Healthy Subjects
Official title: A Randomized, Open-label, Three-period, Three-sequence, Multiple Dosing Crossover, Phase 1 Clinical Trial to Evaluate the Effect of DWP14012 on the Pharmacokinetics of DWC202201 After Co-administration of DWP14012 and DWC202201 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Drug Drug Interaction
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2023-04-13
Enrollment: 36
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A randomized, open-label, three-period, three-sequence, multiple dosing crossover, phase 1 clinical trial to evaluate the effect of DWP14012 on the pharmacokinetics of DWC202201 after co-administration of DWP14012 and DWC202201 in healthy subjects


Eligibility criteria: Inclusion Criteria:

* Healthy adults aged ≥ 19 and ≤ 50 years at screening
* Subjects with a body weight ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 to ≤ 27.0 kg/m2 at screening

  ※ BMI (kg/m2) = body weight (kg)/\[height (m)\]2
* Subjects who voluntarily decided to participate in the study and provided written consent to follow precautions after receiving a sufficient explanation on this study and fully understanding the information
* Subjects who are eligible to participate in the study at the discretion of the investigator by physical examination, laboratory tests, and investigator questioning, etc.

Exclusion Criteria:

* Subjects with a disease or a history related to hepatobiliary system, kidney(severe kidney disorder ect.), nervous system, respiratory system, digestive system, endocrine system, hematology system, circulatory system(Heart failure, Torsades de pointes ect.), unrinary system, psychiatry ect.
* Subjects with digestive disease(gastrointestinal ulcers, gastritis, stomach cramps, gastroesophageal disease, Crohn's disease) or history of surgery(except appendectomy, hernia surgery) which can affect on saftey and pharmacodynamics
* Subjects with hypersensitivity or history of clinically significant hypersensitivity to drugs including potassium competitive acid blocker \[P-CAB\] class, aspirin, antibiotics, etc.
* Subjects with hereditary disorders including galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc.
* Subjects with history of inherited muscle disorders
* Subjects with a history of drug abuse or a positive result of using abusive drugs in the urine drug screen
* Subjects who participated in other clinical trials (including bioequivalence studies) within 6 months prior to the first scheduled dose of the IP
* Subjects who donated whole blood within 2 months, donated blood components within 1 month, or received blood transfusion within 1 month prior to the first scheduled dose
* Subjects who are unable to refrain from grapefruit-containing products from 3 days prior to the first scheduled dose until last discharge from hospital
* Subjects or their spouses or partners who are unable to use medically acceptable appropriate double-method of contraception or medically acceptable contraception throughout the study period and for at least 4 weeks after the last IP administration
* Subjects who are unable to refrain from smoking(\>10pieces/day) from 3 days prior to the first scheduled dose until last discharge from hospital
* Subjects with alchoholic disorders or subjects who are unable to refrain from drinking(\>21units/week) from 3 days prior to the first scheduled dose until last discharge from hospital
* Subjects who are unable to refrain from caffein(\>5units/day) from 3 days prior to the first scheduled dose until last discharge from hospital

Primary outcomes:
measure: Atorvastatin Peak Plasma Concentration at steady state (Cmax,ss) after DWC202201 multiple dosing
timeFrame: [Time Frame: up to 64 days]
measure: Atorvastatin Area under the plasma concentration versus time curve at steady state (AUCinf, ss) after DWC202201 multiple dosing
timeFrame: [Time Frame: up to 64 days]
Secondary outcomes:
measure: Atorvastatin Area under the plasma concentration extrapolated to infinity at steady state (AUC,ss) after DWC202201 multiple dosing
timeFrame: [Time Frame: up to 64 days]
measure: Atorvastatin Time to peak drug concentration at staedy state (Tmax, ss) after DWC202201 multiple dosing
timeFrame: [Time Frame: up to 64 days]
measure: Atorvastatin Terminal Half-life at steady state (T1/2,ss) after DWC202201 multiple dosing
timeFrame: [Time Frame: up to 64 days]
measure: Atorvastatin Apparent total body clearance at steady state (CLss/F) after DWC202201 multiple dosing
timeFrame: [Time Frame: up to 64 days]
measure: Atorvastatin Apparent volume of distribution at steady state (Vd,ss/F) after DWC202201 multiple dosing
timeFrame: [Time Frame: up to 64 days]
measure: Atorvastatin active metabolite Area under the plasma concentration versus time curve at steady state (AUCinf, ss) after DWC202201 multiple dosing
timeFrame: [Time Frame: up to 64 days]
measure: Atorvastatin active metabolite Terminal Half-life at steady state (T1/2,ss) after DWC202201 multiple dosing
timeFrame: [Time Frame: up to 64 days]
measure: Atorvastatin active metabolite An estimate of the total body clearance at steady state (CL ss/F) after DWC202201 multiple dosing
timeFrame: [Time Frame: up to 64 days]
measure: Atorvastatin active metabolite Apparent volume of distribution at steady state (Vd,ss/F) after DWC202201 multiple dosing
timeFrame: [Time Frame: up to 64 days]
measure: Atorvastatin active metabolite metabolic ratio after DWC202201 multiple dosing
timeFrame: [Time Frame: up to 64 days]
measure: Fexuprazan Peak Plasma Concentration (Cmax) after DWP14012 single dosing
timeFrame: [Time Frame: up to 64 days]
measure: Fexuprazan Area under the plasma drug concentration-time curve from 0 to tau (AUCtau) after DWP14012 single dosing
timeFrame: [Time Frame: up to 64 days]
measure: Fexuprazan Area under the plasma drug concentration-time curve from 0 to infinity(AUCinf) after DWP14012 single dosing
timeFrame: [Time Frame: up to 64 days]
measure: Fexuprazan The time of peak concentration (Tmax) after DWP14012 single dosing
timeFrame: [Time Frame: up to 64 days]
measure: Fexuprazan Terminal Half-life (t1/2) after DWP14012 single dosing
timeFrame: [Time Frame: up to 64 days]
measure: Fexuprazan Apparent Clearance (CL/F) after DWP14012 single dosing
timeFrame: [Time Frame: up to 64 days]
measure: Fexuprazan Apparent Volume of Distribution After extravascular administration (Vd/F) after DWP14012 single dosing
timeFrame: [Time Frame: up to 64 days]
measure: Fexuprazan Peak Plasma Concentration at steady state (Cmax,ss) after DWP14012 multiple dosing
timeFrame: [Time Frame: up to 64 days]
measure: Fexuprazan Area under the plasma drug concentration-time curve from 0 to tau at steady state (AUCtau,ss) after DWP14012 multiple dosing
timeFrame: [Time Frame: up to 64 days]
measure: Fexuprazan Area under the plasma drug concentration-time curve from 0 to infinity at steady state (AUCinf,ss) after DWP14012 multiple dosing
timeFrame: [Time Frame: up to 64 days]
measure: Fexuprazan Time of Maximum Concentration at steady state (Tmax,ss) after DWP14012 multiple dosing
timeFrame: [Time Frame: up to 64 days]
measure: Fexuprazan Terminal Half-life at steady state (t1/2,ss) after DWP14012 multiple dosing
timeFrame: [Time Frame: up to 64 days]
measure: Fexuprazan An estimate of the total body clearance at steady state (CL ss/F) after DWP14012 multiple dosing
timeFrame: [Time Frame: up to 64 days]
measure: Fexuprazan Aapparent volume of distribution after extravascular administration at steady state (Vd,ss/F) after DWP14012 multiple dosing
timeFrame: [Time Frame: up to 64 days]
measure: Fexuprazan Accumulation ratio after DWP14012 multiple dosing
timeFrame: [Time Frame: up to 64 days]
measure: Fexuprazan active metabolite Peak Plasma Concentration (Cmax) after single dosing
timeFrame: [Time Frame: up to 64 days]
measure: Fexuprazan active metabolite Area under the plasma drug concentration-time curve from 0 to tau (AUCtau) after single dosing
timeFrame: [Time Frame: up to 64 days]
measure: Fexuprazan active metabolite Area under the plasma concentration extrapolated to infinity (AUCinf) after single dosing
timeFrame: [Time Frame: up to 64 days]
measure: Fexuprazan active metabolite The time of peak concentration (Tmax) after single dosing
timeFrame: [Time Frame: up to 64 days]
measure: Fexuprazan active metabolite metabolic ratio after single dosing
timeFrame: [Time Frame: up to 64 days]
measure: Fexuprazan active metabolite Peak Plasma Concentration at steady state (Cmax,ss) after multiple dosing
timeFrame: [Time Frame: up to 64 days]
measure: Fexuprazan active metabolite AUCtau,ss AUCinf,ss Tmax,ss metabolic ratio
timeFrame: [Time Frame: up to 64 days]
measure: Fexuprazan active metabolite Area under the plasma drug concentration-time curve from 0 to tau at steady state (AUCtau,ss) after multiple dosing
timeFrame: [Time Frame: up to 64 days]
measure: Fexuprazan active metabolite Area under the plasma concentration extrapolated to infinity at steady state (AUCinf,ss) after multiple dosing
timeFrame: [Time Frame: up to 64 days]
measure: Fexuprazan active metabolite The time of peak concentration at steady state (Tmax,ss) after multiple dosing
timeFrame: [Time Frame: up to 64 days]
measure: Fexuprazan active metabolite metabolic ratio after multiple dosing
timeFrame: [Time Frame: up to 64 days]
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: