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NCT04335526 Clinical Trial

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

Human Microbiome Clinical Trial

Official title:
A Clinical Study for Assessing the Effect of Change of Bile Acid Pool on the Pharmacodynamics and Safety of Metformin and Intestinal Microbiome Profiles in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04335526
Other study ID # MMP2
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date May 1, 2020
Est. completion date October 21, 2020

Study information
Verified date March 2021
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date October 21, 2020
Est. primary completion date July 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 19 Years to 50 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Cholestyramine Resin
Change bile acid pool by cholestyramine treatment

Locations
Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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)
Primary 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)
Primary 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
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