The Effects of PXR Activation on Hepatic Fat Content
Phase 4
Completed
- Conditions
- Non-alcoholic Fatty Liver Disease
- Interventions
- Drug: Placebo
- Registration Number
- NCT02329405
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo tablet once a day orally for a week. Rifampicin Rifampicin Rifampicin 600 mg tablet once a day orally for a week.
- Primary Outcome Measures
Name Time Method Hepatic fat fraction Day 8
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Oulu University Hospital
🇫🇮Oulu, Finland