Phase 1 Clinical Trial to Evaluate the Effect of DWP14012 on the Pharmacokinetics of DWC202201 in Healthy Subjects
Phase 1
Active, not recruiting
- Conditions
- Drug Drug Interaction
- Interventions
- Drug: DWC202201
- Registration Number
- NCT05812404
- Lead Sponsor
- Daewoong Pharmaceutical Co. LTD.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 36
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Cohort 1 DWP14012 * Treatment A: DWC202201 40 mg qd for 7 days * Treatment B: DWP14012 40 mg qd for 7 days, followed by DWC202201 40 mg qd + DWP14012 40 mg qd for 7 days * Treatment C: DWP14012 40 mg qd for 14 days Cohort 1 DWC202201 * Treatment A: DWC202201 40 mg qd for 7 days * Treatment B: DWP14012 40 mg qd for 7 days, followed by DWC202201 40 mg qd + DWP14012 40 mg qd for 7 days * Treatment C: DWP14012 40 mg qd for 14 days Cohort 2 DWP14012 * Treatment C: DWP14012 40 mg qd for 14 days * Treatment A: DWC202201 40 mg qd for 7 days * Treatment B: DWP14012 40 mg qd for 7 days, followed by DWC202201 40 mg qd + DWP14012 40 mg qd for 7 days Cohort 2 DWC202201 * Treatment C: DWP14012 40 mg qd for 14 days * Treatment A: DWC202201 40 mg qd for 7 days * Treatment B: DWP14012 40 mg qd for 7 days, followed by DWC202201 40 mg qd + DWP14012 40 mg qd for 7 days Cohort 3 DWP14012 * Treatment B: DWP14012 40 mg qd for 7 days, followed by DWC202201 40 mg qd + DWP14012 40 mg qd for 7 days * Treatment C: DWP14012 40 mg qd for 14 days * Treatment A: DWC202201 40 mg qd for 7 days Cohort 3 DWC202201 * Treatment B: DWP14012 40 mg qd for 7 days, followed by DWC202201 40 mg qd + DWP14012 40 mg qd for 7 days * Treatment C: DWP14012 40 mg qd for 14 days * Treatment A: DWC202201 40 mg qd for 7 days
- Primary Outcome Measures
Name Time Method Atorvastatin Peak Plasma Concentration at steady state (Cmax,ss) after DWC202201 multiple dosing [Time Frame: up to 64 days] Atorvastatin Area under the plasma concentration versus time curve at steady state (AUCinf, ss) after DWC202201 multiple dosing [Time Frame: up to 64 days]
- Secondary Outcome Measures
Name Time Method Atorvastatin active metabolite Area under the plasma concentration versus time curve at steady state (AUCinf, ss) after DWC202201 multiple dosing [Time Frame: up to 64 days] Atorvastatin active metabolite An estimate of the total body clearance at steady state (CL ss/F) after DWC202201 multiple dosing [Time Frame: up to 64 days] Atorvastatin active metabolite Apparent volume of distribution at steady state (Vd,ss/F) after DWC202201 multiple dosing [Time Frame: up to 64 days] Atorvastatin Area under the plasma concentration extrapolated to infinity at steady state (AUC,ss) after DWC202201 multiple dosing [Time Frame: up to 64 days] Atorvastatin Time to peak drug concentration at staedy state (Tmax, ss) after DWC202201 multiple dosing [Time Frame: up to 64 days] Atorvastatin Terminal Half-life at steady state (T1/2,ss) after DWC202201 multiple dosing [Time Frame: up to 64 days] Atorvastatin Apparent total body clearance at steady state (CLss/F) after DWC202201 multiple dosing [Time Frame: up to 64 days] Atorvastatin Apparent volume of distribution at steady state (Vd,ss/F) after DWC202201 multiple dosing [Time Frame: up to 64 days] Fexuprazan Area under the plasma drug concentration-time curve from 0 to tau (AUCtau) after DWP14012 single dosing [Time Frame: up to 64 days] Atorvastatin active metabolite Terminal Half-life at steady state (T1/2,ss) after DWC202201 multiple dosing [Time Frame: up to 64 days] Fexuprazan Peak Plasma Concentration (Cmax) after DWP14012 single dosing [Time Frame: up to 64 days] Fexuprazan Terminal Half-life (t1/2) after DWP14012 single dosing [Time Frame: up to 64 days] Fexuprazan Apparent Clearance (CL/F) after DWP14012 single dosing [Time Frame: up to 64 days] Fexuprazan Apparent Volume of Distribution After extravascular administration (Vd/F) after DWP14012 single dosing [Time Frame: up to 64 days] Fexuprazan Peak Plasma Concentration at steady state (Cmax,ss) after DWP14012 multiple dosing [Time Frame: up to 64 days] Fexuprazan Area under the plasma drug concentration-time curve from 0 to tau at steady state (AUCtau,ss) after DWP14012 multiple dosing [Time Frame: up to 64 days] Fexuprazan Time of Maximum Concentration at steady state (Tmax,ss) after DWP14012 multiple dosing [Time Frame: up to 64 days] Fexuprazan Aapparent volume of distribution after extravascular administration at steady state (Vd,ss/F) after DWP14012 multiple dosing [Time Frame: up to 64 days] Atorvastatin active metabolite metabolic ratio after DWC202201 multiple dosing [Time Frame: up to 64 days] Fexuprazan Terminal Half-life at steady state (t1/2,ss) after DWP14012 multiple dosing [Time Frame: up to 64 days] Fexuprazan An estimate of the total body clearance at steady state (CL ss/F) after DWP14012 multiple dosing [Time Frame: up to 64 days] Fexuprazan active metabolite The time of peak concentration (Tmax) after single dosing [Time Frame: up to 64 days] Fexuprazan active metabolite metabolic ratio after single dosing [Time Frame: up to 64 days] Fexuprazan active metabolite Peak Plasma Concentration at steady state (Cmax,ss) after multiple dosing [Time Frame: up to 64 days] Fexuprazan active metabolite AUCtau,ss AUCinf,ss Tmax,ss metabolic ratio [Time Frame: up to 64 days] Fexuprazan active metabolite Area under the plasma drug concentration-time curve from 0 to tau at steady state (AUCtau,ss) after multiple dosing [Time Frame: up to 64 days] Fexuprazan active metabolite Area under the plasma concentration extrapolated to infinity at steady state (AUCinf,ss) after multiple dosing [Time Frame: up to 64 days] Fexuprazan active metabolite The time of peak concentration at steady state (Tmax,ss) after multiple dosing [Time Frame: up to 64 days] Fexuprazan active metabolite metabolic ratio after multiple dosing [Time Frame: up to 64 days] Fexuprazan Area under the plasma drug concentration-time curve from 0 to infinity(AUCinf) after DWP14012 single dosing [Time Frame: up to 64 days] Fexuprazan The time of peak concentration (Tmax) after DWP14012 single dosing [Time Frame: up to 64 days] Fexuprazan Area under the plasma drug concentration-time curve from 0 to infinity at steady state (AUCinf,ss) after DWP14012 multiple dosing [Time Frame: up to 64 days] Fexuprazan Accumulation ratio after DWP14012 multiple dosing [Time Frame: up to 64 days] Fexuprazan active metabolite Peak Plasma Concentration (Cmax) after single dosing [Time Frame: up to 64 days] Fexuprazan active metabolite Area under the plasma drug concentration-time curve from 0 to tau (AUCtau) after single dosing [Time Frame: up to 64 days] Fexuprazan active metabolite Area under the plasma concentration extrapolated to infinity (AUCinf) after single dosing [Time Frame: up to 64 days]
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of