The effects of PXR activation on hepatic fat content

Phase 1

• Conditions: Healthy volunteers; MedDRA version: 17.0Level: LLTClassification code 10024681Term: Liver fatty changeSystem Organ Class: 100000004871; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2014-003422-41-FI
• Lead Sponsor: Oulu University Hospital, Department of Internal Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-01
• Last Update Posted: 7 May 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Healthy volunteers
18-40 years of age
Body mass index (BMI) 18.5-25 kg/m2

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 clinical trial of medicinal product
• Study Design: Not specified