A Clinical Study to Assess the Effect of Change of Bile Acid on the PD and Safety of Metformin and Microbiome Profiles

NCT04335526 | Completed Phase 1

• 1 other identifier: MMP2
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial is intended to evaluate the effect of change of bile acid pool with cholestyramine on the pharmacodynamics and safety of metformin and intestinal microbiome profiles in healthy volunteers

Conditions

Human Microbiome

Outcome Measures

Primary Outcomes (3)

• Compare the maximum blood glucose concentration (Gmax)

  Compare the maximum blood glucose concentration (Gmax) between meformin alone and meformin with cholestyramine

  Day 1/2/8/9 (pre-dose (75 g glucose), 0.25, 0.5, 0.75, 1, 1.5. 2 hours)

• Compare the maximum blood glucose concentration (Gmax)

  Compare the area under the blood glucose concentration versus time curve (AUC) between meformin alone and meformin with cholestyramine

  Day 1/2/8/9 (pre-dose (75 g glucose), 0.25, 0.5, 0.75, 1, 1.5. 2 hours)

• Compare the gut microbiome species change

  Compare how the gut microbiome species change between meformin alone and meformin with cholestyramine

  Day 1/2/8/9

Study Arms (2)

Metformin alone

NO INTERVENTION

Metformin with cholestyramine

OTHER

Drug: Cholestyramine Resin

Interventions

Cholestyramine Resin DRUG

Change bile acid pool by cholestyramine treatment

Metformin with cholestyramine

Eligibility Criteria

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

You may qualify if:

• Age between 19 to 50, healthy male subjects(at screening)
• Body weight between 50.0 kg - 100.0 kg, BMI between 18.0 - 28.0 kg/m2
• Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress

You may not qualify if:

• Subject who has a past or present history of any diseases following below.(liver, kidney, neurology, immunology, pulmonary, endocrine, hematology, oncology, cardiology, mental disorder)
• Subject who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery (appendectomy, hernioplasty are excluded)
• Serum AST(SGOT), ALT(SGPT)\>2 times upper limit of normal range MDRD eGFR \<80mL/min/1.73m2
• Subject who had drug (Aspirin, antibiotics) hypersensitivity reaction
• Subject who already participated in other trials in 3 months
• Subject who had whole blood donation in 2 months, or component blood donation in 1 month or transfusion in 1 month currently

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Cholestyramine Resin

Intervention Hierarchy (Ancestors)

Polystyrenes; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Chung Jae Yong, MD, PhD

  Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 6, 2020
• Study Start: May 1, 2020
• Primary Completion: July 30, 2020
• Study Completion: October 21, 2020
• Last Updated: March 17, 2021

Record last verified: 2021-03

Locations

KR (1)