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Completed

NCT Number: NCT02329405

The Effects of PXR Activation on Hepatic Fat Content

This study investigates the effects of pregnane X receptor (PXR) activation on hepatic fat content in healthy volunteers. Rifampicin (an antibiotic and also an efficient PXR activator) and placebo will be given for a week to volunteers. Hepatic fat content is measured with magnetic resonance imaging and blood samples are collected at the end of each study arm. The investigators' hypothesis is that rifampicin causes accumulation of fat to the liver.

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Key information

Conditions

Non-Alcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Liver Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Oulu University Hospital

Oulu, 90029 OYS, Finland

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy volunteers
  • Body mass index (BMI) 18.5-25 kg/m2

Exclusion criteria

  • Systolic blood pressure over 150 mmHg
  • Any continuous medication (hormonal intrauterine device is permitted)
  • Any significant medical condition
  • Insensitivity to rifampicin
  • Pregnancy and lactation
  • Previous difficult venipuncture
  • Alcohol and medicine abuse and drug use
  • Participation to any other pharmaceutical trial within on month of screening
  • Claustrophobia
  • Metal and other implants which are contraindications to MRI

Treatment and study plan

rifampicin

Drug

Other names: Rifampin

Placebo

Drug

Primary outcomes

  1. Hepatic fat fraction

    Time frame: Day 8

Sponsors and collaborators

Lead sponsor

University of Oulu

Other

Collaborators

  • Oulu University Hospital

Registry information

Official study title

PXR-aktivaation Vaikutus Maksan Rasvoittumiseen

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 31, 2014
Registry last updated
Nov 1, 2017

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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