Phase 1 Clinical Trial to Evaluate the Effect of DWP14012 on the Pharmacokinetics of DWC202201 in Healthy Subjects

Drug Drug Interaction Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05812404
• Other study ID #: DW_DWP14012109
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: October 26, 2022
• Est. completion date: June 16, 2023

Study information

• Verified date: April 2023
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: June 16, 2023
• Est. primary completion date: March 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug Drug Interaction

Intervention

Drug:
• DWP14012
Potassium-competitive acid blocker
• DWC202201
Atorvastatin Calcium Trihydrate

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atorvastatin Peak Plasma Concentration at steady state (Cmax,ss) after DWC202201 multiple dosing		[Time Frame: up to 64 days]
Primary	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	Atorvastatin Area under the plasma concentration extrapolated to infinity at steady state (AUC,ss) after DWC202201 multiple dosing		[Time Frame: up to 64 days]
Secondary	Atorvastatin Time to peak drug concentration at staedy state (Tmax, ss) after DWC202201 multiple dosing		[Time Frame: up to 64 days]
Secondary	Atorvastatin Terminal Half-life at steady state (T1/2,ss) after DWC202201 multiple dosing		[Time Frame: up to 64 days]
Secondary	Atorvastatin Apparent total body clearance at steady state (CLss/F) after DWC202201 multiple dosing		[Time Frame: up to 64 days]
Secondary	Atorvastatin Apparent volume of distribution at steady state (Vd,ss/F) after DWC202201 multiple dosing		[Time Frame: up to 64 days]
Secondary	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]
Secondary	Atorvastatin active metabolite Terminal Half-life at steady state (T1/2,ss) after DWC202201 multiple dosing		[Time Frame: up to 64 days]
Secondary	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]
Secondary	Atorvastatin active metabolite Apparent volume of distribution at steady state (Vd,ss/F) after DWC202201 multiple dosing		[Time Frame: up to 64 days]
Secondary	Atorvastatin active metabolite metabolic ratio after DWC202201 multiple dosing		[Time Frame: up to 64 days]
Secondary	Fexuprazan Peak Plasma Concentration (Cmax) after DWP14012 single dosing		[Time Frame: up to 64 days]
Secondary	Fexuprazan Area under the plasma drug concentration-time curve from 0 to tau (AUCtau) after DWP14012 single dosing		[Time Frame: up to 64 days]
Secondary	Fexuprazan Area under the plasma drug concentration-time curve from 0 to infinity(AUCinf) after DWP14012 single dosing		[Time Frame: up to 64 days]
Secondary	Fexuprazan The time of peak concentration (Tmax) after DWP14012 single dosing		[Time Frame: up to 64 days]
Secondary	Fexuprazan Terminal Half-life (t1/2) after DWP14012 single dosing		[Time Frame: up to 64 days]
Secondary	Fexuprazan Apparent Clearance (CL/F) after DWP14012 single dosing		[Time Frame: up to 64 days]
Secondary	Fexuprazan Apparent Volume of Distribution After extravascular administration (Vd/F) after DWP14012 single dosing		[Time Frame: up to 64 days]
Secondary	Fexuprazan Peak Plasma Concentration at steady state (Cmax,ss) after DWP14012 multiple dosing		[Time Frame: up to 64 days]
Secondary	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]
Secondary	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]
Secondary	Fexuprazan Time of Maximum Concentration at steady state (Tmax,ss) after DWP14012 multiple dosing		[Time Frame: up to 64 days]
Secondary	Fexuprazan Terminal Half-life at steady state (t1/2,ss) after DWP14012 multiple dosing		[Time Frame: up to 64 days]
Secondary	Fexuprazan An estimate of the total body clearance at steady state (CL ss/F) after DWP14012 multiple dosing		[Time Frame: up to 64 days]
Secondary	Fexuprazan Aapparent volume of distribution after extravascular administration at steady state (Vd,ss/F) after DWP14012 multiple dosing		[Time Frame: up to 64 days]
Secondary	Fexuprazan Accumulation ratio after DWP14012 multiple dosing		[Time Frame: up to 64 days]
Secondary	Fexuprazan active metabolite Peak Plasma Concentration (Cmax) after single dosing		[Time Frame: up to 64 days]
Secondary	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]
Secondary	Fexuprazan active metabolite Area under the plasma concentration extrapolated to infinity (AUCinf) after single dosing		[Time Frame: up to 64 days]
Secondary	Fexuprazan active metabolite The time of peak concentration (Tmax) after single dosing		[Time Frame: up to 64 days]
Secondary	Fexuprazan active metabolite metabolic ratio after single dosing		[Time Frame: up to 64 days]
Secondary	Fexuprazan active metabolite Peak Plasma Concentration at steady state (Cmax,ss) after multiple dosing		[Time Frame: up to 64 days]
Secondary	Fexuprazan active metabolite AUCtau,ss AUCinf,ss Tmax,ss metabolic ratio		[Time Frame: up to 64 days]
Secondary	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]
Secondary	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]
Secondary	Fexuprazan active metabolite The time of peak concentration at steady state (Tmax,ss) after multiple dosing		[Time Frame: up to 64 days]
Secondary	Fexuprazan active metabolite metabolic ratio after multiple dosing		[Time Frame: up to 64 days]