to Evaluate the Safety/Tolerability and Pharmacokinetics, and Pharmacodynamics of DWP14012 Injection

NCT06437951 | Not Yet Recruiting Phase 1

• 1 other identifier: DW_DWJ1521104
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

to evaluate the safety/tolerability and pharmacokinetics, and pharmacodynamics after intravenous DWP14012 injection in healthy participants

Conditions

Erosive Gastroesophageal Reflux Disease

Outcome Measures

Primary Outcomes (3)

• PK of Fexuprazan

  1\. Blood and urinary concentrations of Fexuprazan by part

  0 and 72hour

• PK of metabolite

  1\. Blood and urinary concentrations of metabolite by part

  0 and 72hour

• PD of Fexuprazan

  pH monitoring

  up to 15days

Study Arms (5)

Part1_test group

EXPERIMENTAL

IV injection of test drugs by dose group

Drug: Fexuprazan Injection

Part1_placebo group

PLACEBO COMPARATOR

IV injection of test drugs by dose group

Drug: Fexuprazan Injection placebo

Part2

EXPERIMENTAL

All Participants take IV injection of test drugs

Drug: Fexuprazan Injection_part 2

Part3_test group

EXPERIMENTAL

In the case of test group, take IV injection in the period 1 and take a tablet in the period 2

Drug: Fexuprazan Injection_part 3; Drug: Fexuprazan tablet

Part3_reference group

ACTIVE COMPARATOR

In the case of reference group, take a tablet in the period 1 and take IV injection in the period 2

Drug: Fexuprazan Injection_part 3; Drug: Fexuprazan tablet

Interventions

Fexuprazan Injection DRUG

20/40/80 mg

Part1_test group

Fexuprazan Injection placebo DRUG

20/40/80 mg

Part1_placebo group

Fexuprazan Injection_part 2 DRUG

20mg

Part2

Fexuprazan Injection_part 3 DRUG

40mg

Part3_reference group; Part3_test group

Fexuprazan tablet DRUG

40mg

Part3_reference group; Part3_test group

Eligibility Criteria

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

You may qualify if:

• Healthy adult volunteers aged 19 to 50 at the time of screening tests
• Those who weigh more than 50.0 kg, 90.0 kg or less, and have a BMI of 18.5 or more and 29.9 or less at the time of screening inspection BMI (kg/m2) = Weight (kg) / {Height (m)}2
• In the case of female volunteers, those who are not necessarily pregnant or lactating or who are in surgical infertility (bilateral ovarian obstruction, hysterectomy, bilateral ovarian resection, etc.)
• A person who voluntarily decides to participate after hearing and fully understanding the detailed explanation of this clinical trial and agrees in writing before a screening procedure
• A person who is suitable for this test when judging the tester by physical examination, clinical laboratory examination, questionnaire, etc

You may not qualify if:

• Clinically significant hepatomegaly (severe liver disorder, viral hepatitis, etc.), kidney (severe renal disorder, etc.), nervous system, immune system, respiratory system, digestive system, endocrine system, blood and tumor, cardiovascular system (heart failure, Torsades de points, etc.), urinary system, mental system (fever disorder, obsessive compulsive disorder, etc.), sexual dysfunction, etc
• A person who has a history of gastrointestinal diseases (such as Crohn's disease, ulcers, gastritis, gastritis, gastroesophageal reflux disease, etc.) or surgery (except simple appendectomy or hernia) that may affect the safety, pharmacokinetics and pharmacodynamic evaluation of clinical medicines
• Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
• A person who has been tested positive for Helicobacter pylori
• Those who have anatomical impairments in insertion and maintenance of the pH meter catheter etc

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

MeSH Terms

Interventions

fexuprazan

Study Officials

• Injin zhang, Ph.D

  Seoul National University College of Medicine and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sujong Lee, Ph.D

CONTACT

027408910; leesj0323@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 31, 2024
• Study Start: July 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: May 1, 2025
• Last Updated: June 3, 2024

Record last verified: 2024-05