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

NCT ID: NCT05812404

Last Updated: 2023-04-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-26
• Study Completion Date: 2023-06-16

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

Conditions

Drug Drug Interaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1

• 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

Group Type: EXPERIMENTAL

DWP14012

Intervention Type: DRUG

Potassium-competitive acid blocker

DWC202201

Intervention Type: DRUG

Atorvastatin Calcium Trihydrate

Cohort 2

• 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

Group Type: EXPERIMENTAL

DWP14012

Intervention Type: DRUG

Potassium-competitive acid blocker

DWC202201

Intervention Type: DRUG

Atorvastatin Calcium Trihydrate

Cohort 3

• 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

Group Type: EXPERIMENTAL

DWP14012

Intervention Type: DRUG

Potassium-competitive acid blocker

DWC202201

Intervention Type: DRUG

Atorvastatin Calcium Trihydrate

Interventions

DWP14012

Potassium-competitive acid blocker

Intervention Type: DRUG

DWC202201

Atorvastatin Calcium Trihydrate

Intervention Type: DRUG

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

DW_DWP14012109

Identifier Type: -

Identifier Source: org_study_id