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

NCT05816681 | Completed Phase 1

• 1 other identifier: DWJ1230101
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diarrhea

Outcome Measures

Primary Outcomes (1)

• To assess the concentration of lead in blood after administration of Investigational Product

  Day 7

Secondary Outcomes (2)

• 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

Study Arms (2)

DWJ1230

EXPERIMENTAL

Drug: DWJ1230

DWB2001

EXPERIMENTAL

Drug: DWB2001

Interventions

DWJ1230 DRUG

Daewoong Pharmaceutical

DWJ1230

DWB2001 DRUG

Daewoong Bio

DWB2001

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

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

Seoul, South Korea

Location

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: April 18, 2023
• Study Start: August 22, 2022
• Primary Completion: February 6, 2023
• Study Completion: April 10, 2023
• Last Updated: April 19, 2023

Record last verified: 2023-04

Locations

KR (1)