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Completed

NCT Number: NCT04335526

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

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

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Key information

Conditions

Human Microbiome

Age range

19 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Bundang Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholestyramine Resin

Drug

Change bile acid pool by cholestyramine treatment

Primary outcomes

  1. Compare the maximum blood glucose concentration (Gmax)

    Time frame: 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

  2. Compare the maximum blood glucose concentration (Gmax)

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

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

  3. Compare the gut microbiome species change

    Time frame: Day 1/2/8/9

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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 6, 2020
Registry last updated
Mar 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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