Healthy volunteers MedDRA version: 17.0 Level: LLT Classification code 10024681 Term: Liver fatty change System Organ Class: 100000004871
Conditions
Sponsors
Oulu University Hospital, Department of Internal Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study how PXR activation by rifampicin affects hepatic fat content;Secondary Objective: To study how PXR activation by rifampicin affects plasma alkaline phosphatase;Primary end point(s): Hepatic fat fraction as measured by MRI;Timepoint(s) of evaluation of this end point: At the end of both arms on Day 8 after the one-week treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Bone alkaline phosphatase level in plasma;Timepoint(s) of evaluation of this end point: At the end of both arms on Day 8 after the one-week treatment. | — |
Countries
Finland
Contacts
Public Contactjanne.hukkanen@oulu.fi
Oulu University Hospital, Department of Internal Medicine
Outcome results
None listed