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

NCT05812404 | Unknown Phase 1

• 1 other identifier: DW_DWP14012109
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (36)

• 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]

Study Arms (3)

Cohort 1

EXPERIMENTAL

* 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

Drug: DWP14012; Drug: DWC202201

Cohort 2

EXPERIMENTAL

* 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

Drug: DWP14012; Drug: DWC202201

Cohort 3

EXPERIMENTAL

* 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

Drug: DWP14012; Drug: DWC202201

Interventions

DWP14012 DRUG

Potassium-competitive acid blocker

Cohort 1; Cohort 2; Cohort 3

DWC202201 DRUG

Atorvastatin Calcium Trihydrate

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Interventions

fexuprazan

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: April 13, 2023
• Study Start: October 26, 2022
• Primary Completion: March 28, 2023
• Study Completion: June 16, 2023
• Last Updated: April 13, 2023

Record last verified: 2023-04

Locations

KR (1)