Drug-Drug Interaction Study to Investigate Effects of Voclosporin on Pharmacokinetics of Simvastatin

Inclusion criteria

• Written informed consent
• Healthy male or female subjects aged >=18 and <=55 years
• Body mass index >=18.0 and <32 kg/m2

Exclusion criteria

• Abnormal ECG and/or prolonged QT interval
• Subjects using nicotine products within 3 months prior to screening
• Subjects who have lost or donated >450 mL of whole blood or blood products within 30 days prior to the Screening Visit.
• Use of any prescription medication within 14 days prior to the first dose of study medication, or any over-the-counter products (including natural health products, e.g., food supplements, vitamins, herbal supplements) within 7 days prior to the first dose of study medication, except for topical products without significant systemic absorption.
• Use of any drugs or substances known to induce or inhibit hepatic drug metabolism within 28 days prior to administration of the study medication
• Consumption of grapefruit or grapefruit juice, pomelo or star fruit within 7 days of first dose of study drug on Day 1
• Use of hormonal contraception or hormone replacement therapy within 14 days prior to first dose of study drug.
• No COVID-19 vaccines are allowed within 28 days prior to first dose of study drug.
• History of or current alcohol abuse or drug addiction
• Subjects who are pregnant or breast feeding
• Subjects who have received any investigational drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to screening.
• Subjects who have any significant health issues as deemed by their treating physician/investigator