Healthy
Conditions
Brief summary
The purpose of this study is to estimate the prevalence of genetic variants associated with liver disease in participants who are known, or are likely to have NAFLD.
Interventions
OTHERNo intervention
No investigational medicinal product will be administered as a part of this study.
Sponsors
Janssen Research & Development, LLC
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* No clinically significant abnormality based on medical history, physical exam, and 12-lead electrocardiogram (ECG) collected during Visit 1 * Women must be of non-childbearing potential, defined as either: a.) Postmenopausal or b.) Permanently sterile * Must be willing to provide a deoxyribonucleic acid (DNA) sample for assessment of genetic variants associated with NAFLD * Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
Exclusion criteria
* History or presence of drug abuse within the 2 years prior to Visit 1 * Excessive use of alcohol within 2 years prior to the study * Body mass index greater than (\>) 40 kilogram per meter square (kg/m\^2) * Evidence of other active (acute or chronic) liver disease other than NAFLD/ Nonalcoholic steatohepatitis (NASH) * History of bariatric surgery or planning to undergo bariatric surgery within the next year * Inability to undergo magnetic resonance imaging (MRI)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of Genetic Variants Associated with NAFLD | Up to 8 weeks | Genotyping for known mutations associated with NAFLD will be conducted and the prevalence in the overall population enrolled will be calculated. |
| Liver Fat Content Estimated with Fibroscan | Up to 8 weeks | Fibroscan will be performed to obtain the controlled attenuation parameter (CAP) score to estimate liver fat content. Number of participants with a CAP score greater or equal to (\>=) 310 decibels per minute (dB/m) (that is, liver fat \>= 10 percent \[%\]) will be estimated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Liver Fibrosis Estimated with Fibroscan | Up to 8 weeks | Fibroscan will be conducted to obtain liver stiffness measurement to estimate liver fibrosis. Number of participants with absent, low or moderate fibrosis (that is, less than or equal to (\<=) 9 kilopascals \[kPa\]) will be estimated. |
| Hepatic Fat Fraction | Up to 8 weeks | The liver fat fraction will be obtained by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) to estimate the inter-participant variability in liver fat measurement. |
Countries
United States
Outcome results
None listed