The Effects of PXR Activation on Hepatic Fat Content
PXR-aktivaation Vaikutus Maksan Rasvoittumiseen
2 other identifiers
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Dec 2014
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 29, 2014
CompletedFirst Posted
Study publicly available on registry
December 31, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedNovember 1, 2017
October 1, 2017
2.1 years
December 29, 2014
October 31, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Hepatic fat fraction
Day 8
Study Arms (2)
Rifampicin
EXPERIMENTALRifampicin 600 mg tablet once a day orally for a week.
Placebo
PLACEBO COMPARATORPlacebo tablet once a day orally for a week.
Interventions
Eligibility Criteria
You may qualify if:
- Healthy volunteers
- Body mass index (BMI) 18.5-25 kg/m2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Oululead
- Oulu University Hospitalcollaborator
Study Sites (1)
Oulu University Hospital
Oulu, 90029 OYS, Finland
Related Publications (1)
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.
PMID: 35229613DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Janne Hukkanen, MD, PhD
Oulu University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 29, 2014
First Posted
December 31, 2014
Study Start
December 1, 2014
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
November 1, 2017
Record last verified: 2017-10