ClinicalTrials.gg
Status unknownNCT06437951Updated Jun 3, 2024

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

A Phase 1 interventional study of Fexuprazan Injection and Fexuprazan Injection placebo in Erosive Gastroesophageal Reflux Disease, sponsored by Daewoong Pharmaceutical Co. LTD.. Status unknown. Open to participants aged 19 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-03.

Sponsored by Daewoong Pharmaceutical Co. LTD. · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2024), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
19 Years to 50 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Erosive Gastroesophageal Reflux Disease
03

In context

Lead sponsor

Daewoong Pharmaceutical Co. LTD. is the lead sponsor of 200 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Healthy adult volunteers aged 19 to 50 at the time of screening tests
  2. 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
  3. 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.)
  4. 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
  5. A person who is suitable for this test when judging the tester by physical examination, clinical laboratory examination, questionnaire, etc

Exclusion criteria

Exclusion Criteria:

  1. 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
  2. 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
  3. Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
  4. A person who has been tested positive for Helicobacter pylori
  5. Those who have anatomical impairments in insertion and maintenance of the pH meter catheter etc
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Part1_test group

    IV injection of test drugs by dose group

    Drug: Fexuprazan Injection

  • Placebo comparator
    Part1_placebo group

    IV injection of test drugs by dose group

    Drug: Fexuprazan Injection placebo

  • Experimental
    Part2

    All Participants take IV injection of test drugs

    Drug: Fexuprazan Injection_part 2

  • Experimental
    Part3_test group

    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

  • Active comparator
    Part3_reference group

    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

06

What researchers measure

Primary outcomes

  1. PK of Fexuprazan

    1\. Blood and urinary concentrations of Fexuprazan by part

    Time frame: 0 and 72hour

  2. PK of metabolite

    1\. Blood and urinary concentrations of metabolite by part

    Time frame: 0 and 72hour

  3. PD of Fexuprazan

    pH monitoring

    Time frame: up to 15days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06437951
Responsible party
Sponsor
First posted
May 31, 2024
Start date
Jul 2024 (estimated)
Primary completion
Jan 2025 (estimated)
Completion
May 2025 (estimated)
Last update
Jun 3, 2024

Study contacts

Sujong Lee, Ph.D
Contact
leesj0323@snu.ac.kr
027408910
Injin zhang, Ph.D
principal investigator · Seoul National University College of Medicine and Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Fexuprazan

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