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

Completed · Phase 1

Conditions studied: Drug-drug Interaction

In brief

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.

Key facts

Study ID

NCT05306379

Run by

Aurinia Pharmaceuticals Inc.

People needed

24

Starts

2022-01-24

Expected to finish

2022-04-05

Last updated by the study team

2022-04-20

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Labcorp Clinical Research Unit — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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