The Effects of PXR Activation on Hepatic Fat Content

University of Oulu

Status and phase: Completed; Phase 4

Conditions: Non-alcoholic Fatty Liver Disease

Treatments: Drug: Rifampicin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02329405

2014-003422-41 (EudraCT Number)

Rifa-Stea

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups, including a placebo group

Rifampicin

Experimental group

Description:

Rifampicin 600 mg tablet once a day orally for a week.

Treatment:

Drug: Rifampicin

Placebo

Placebo Comparator group

Description:

Placebo tablet once a day orally for a week.

Treatment:

Drug: Placebo