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

• Status: Active, not recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

Summary

A single-center, open-label, Phase 1, drug-drug interaction study to investigate the effect of voclosporin on the pharmacokinetics of simvastatin and simvastatin acid in healthy volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Aurinia Pharmaceuticals Inc.
• Treatments: Simvastatin

Criteria

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