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The Effects of PXR Activation on Hepatic Fat Content

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02329405
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : November 1, 2017
Sponsor:
Collaborator:
Oulu University Hospital
Information provided by (Responsible Party):
University of Oulu

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non-alcoholic Fatty Liver Disease Drug: Rifampicin Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: PXR-aktivaation Vaikutus Maksan Rasvoittumiseen
Study Start Date : December 2014
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Rifampin

Arm Intervention/treatment
Experimental: Rifampicin
Rifampicin 600 mg tablet once a day orally for a week.
Drug: Rifampicin
Other Name: Rifampin

Placebo Comparator: Placebo
Placebo tablet once a day orally for a week.
Drug: Placebo



Primary Outcome Measures :
  1. Hepatic fat fraction [ Time Frame: Day 8 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02329405


Locations
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Finland
Oulu University Hospital
Oulu, Finland, 90029 OYS
Sponsors and Collaborators
University of Oulu
Oulu University Hospital
Investigators
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Principal Investigator: Janne Hukkanen, MD, PhD Oulu University Hospital
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Responsible Party: University of Oulu
ClinicalTrials.gov Identifier: NCT02329405    
Other Study ID Numbers: Rifa-Stea
2014-003422-41 ( EudraCT Number )
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases
Rifampin
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers