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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04335526

Enrollment

Registered

2020-04-06

Start date

2020-05-01

Completion date

2020-10-21

Last updated

2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Microbiome

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

Interventions

DRUGCholestyramine Resin

Change bile acid pool by cholestyramine treatment

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Compare the maximum blood glucose concentration (Gmax)	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) between meformin alone and meformin with cholestyramine
Compare the gut microbiome species change	Day 1/2/8/9	Compare how the gut microbiome species change between meformin alone and meformin with cholestyramine

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026