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NCT02329405 Clinical Trial

The Effects of PXR Activation on Hepatic Fat Content

Non-alcoholic Fatty Liver Disease Clinical Trial

Official title:
PXR-aktivaation Vaikutus Maksan Rasvoittumiseen

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02329405
Other study ID # Rifa-Stea
Secondary ID 2014-003422-41
Status Completed
Phase Phase 4
First received December 29, 2014
Last updated October 31, 2017
Start date December 2014
Est. completion date January 2017

Study information
Verified date October 2017
Source University of Oulu
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date January 2017
Est. primary completion date January 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Rifampicin

• Placebo

Locations
Country Name City State
Finland Oulu University Hospital Oulu

Sponsors (2)
Lead Sponsor Collaborator
University of Oulu Oulu University Hospital

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hepatic fat fraction Day 8
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