CClinicalTrials.gg
Sign In
CompletedNCT02329405Updated Nov 1, 2017

The Effects of PXR Activation on Hepatic Fat Content

A Phase 4 interventional study of Rifampicin and Placebo in Non-alcoholic Fatty Liver Disease, sponsored by University of Oulu. Completed at 1 site in Finland. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-01.

Sponsored by University of Oulu · Phase 4, Interventional, and Basic science

Phase
Phase 4
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Non-alcoholic Fatty Liver Disease
03

In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's enrollment of 16 is below the median of 50 across 1,323 interventional studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

University of Oulu is the lead sponsor of 138 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Rifampicin

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

    Drug: Rifampicin

  • Placebo comparator
    Placebo

    Placebo tablet once a day orally for a week.

    Drug: Placebo

Interventions

  • DrugRifampicin

    Also known as: Rifampin

  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. Hepatic fat fraction

    Time frame: Day 8

07

Study locations

1 site
  • Oulu University Hospital
    Oulu, 90029 OYS, Finland
08

References and documents

Publications

  • Rahunen R, Kummu O, Koivukangas V, Hautajarvi H, Hakkola J, Rysa J, Hukkanen J. Pregnane X Receptor-4beta-Hydroxycholesterol Axis in the Regulation of Overweight- and Obesity-Induced Hypertension. J Am Heart Assoc. 2022 Mar 15;11(6):e023492. doi: 10.1161/JAHA.121.023492. Epub 2022 Mar 1. PubMed 35229613 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02329405
Lead sponsor
University of Oulu
Collaborators
Oulu University Hospital
Responsible party
Sponsor
First posted
Dec 31, 2014
Start date
Dec 2014
Primary completion
Jan 2017
Completion
Jan 2017
Last update
Nov 1, 2017

Study contacts

Janne Hukkanen, MD, PhD
principal investigator · Oulu University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Liver Diseases→

Other studies from this sponsor

University of Oulu

Start the discussion