Drug-Drug Interaction Study to Investigate Effects of Voclosporin on Pharmacokinetics of Simvastatin (Statin-DDI)

Aurinia Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Drug-drug Interaction

Treatments: Drug: Simvastatin; Drug: Voclosporin

Study type: Interventional

Funder types: Industry

Identifiers

NCT05306379

AUR-VCS-2021-02

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Voclosporin/Simvastatin

Experimental group

Description:

Subjects will receive a single oral dose of 40 mg simvastatin (given as two 20 mg tablets) in the morning of Day 1 and Day 8. Subjects will receive voclosporin administered as an oral 23.7 mg dose (three 7.9 mg capsules) twice-daily for 7 days from the morning of Day 2 until the evening of Day 8.

Treatment:

Drug: Simvastatin

Drug: Voclosporin