Assessment of Elemental Impurities Level After Multiple Administration of DWJ1230 or DWB2001 in Subjects With Functional Diarrhea or Irritable Bowel Syndrome With Predominant Diarrhea.

An Open-label, Randomized, Multiple Dose, Parallel Study to Assess Elemental Impurities Level After Multiple Administration of DWJ1230 or DWB2001 in Subjects With Functional Diarrhea or Irritable Bowel Syndrome With Predominant Diarrhea(IBS-D)

This study aims to assess elemental impurities level after dministration of dioctahedral smectite in subjects with functional diarrhea or irritable bowel syndrome with predominant diarrhea. Male or female subjects aged between 19 and 60 years will participate in the study. The study design is an opne-label, randomized, multiple dose paraller study. The patients were randomly assigned to DWJ1230 or DWB2001. It is intended that a total of 60 subjects will be enrolled to ensure that at least 24 subjects will complete the study.

Study Overview

• Status: Completed
• Conditions: Diarrhea
• Intervention / Treatment: Drug: DWJ1230; Drug: DWB2001

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • The Catholic University of Korea, Seoul ST. Mary's Hospital.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subjects with chronic functional Diarrhea. (included Irritable Bowel Syndrome with perdominant diarrhea(IBS-D)).
• Male or Female subjects aged between 19 and 60 years at screening.
• Body Mass Index(BMI) between 18 and 27kg/m2 in male, 17 and 26kg/m2 in female. ※ 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.

Exclusion Criteria:

• No history or clinically significant symptoms or severe disease, including cardiac, neurological, pulmonary, hepatic, biliary, gastrointestinal, endocrinologic, or renal disorders, or cancer.
• Identified or strongly suspected organic cause to diarrhea.
• Celiac disease or Intestinal malabsorption, Unspecified intestinal malabsorption.
• History of any serious adverse reaction or adverse event or hypersensitivity to any component of investigational product.
• Constipation, Iron deficiency anaemia, Hypocalcaemia, Osteoporosis.
• Known domestic, leisure or professional exposure to elemental impurities.
• Women who are breastfeeding or are planning to become pregnant during the study.
• Positive pregnancy test at screening.
• Presence of clinically significant physical, laboratory, vital signs, or ECG findings.
• Blood lead level > 3.3 μg/dL(=33.0 μg/L) at screening.
• galactose intolerance, fructose intolerance, Lapp lactase deficiency, sucurase-isomaltase deficiency, glucose-galactose malabsorption.
• Receipt of any investigational agent or study drug within 4 weeks prior to screening.
• Patients with history of alcohol or drug abuse.
• Subjects who donated whole blood within 2 months, donated blood components within 1 month.
• Subjects who have participated and taken investigational drug within 1 month prior to study drug administration.
• Subjects who the investigator considers inappropriate for the study due to other reasons.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DWJ1230	Drug: DWJ1230; Daewoong Pharmaceutical
Experimental: DWB2001	Drug: DWB2001; Daewoong Bio

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To assess the concentration of lead in blood after administration of Investigational Product	Day 7

Secondary Outcome Measures

Outcome Measure	Time Frame
To assess blood concentration of other Class I(Cadmium, Arsenic, Mercury) after administration of Investigational Product	Day 7
To assess blood concentration of other Class IIa(Cobalt, Nickel) and of aluminium after administration of Investigational Product	Day 7

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2022
• Primary Completion (Actual): February 6, 2023
• Study Completion (Actual): April 10, 2023

Study Registration Dates

• First Submitted: April 4, 2023
• First Submitted That Met QC Criteria: April 4, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 18, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Irritable Bowel Syndrome; Diarrhea
• Other Study ID Numbers: DWJ1230101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No