Drug-Drug Interaction Study to Investigate Effects of Voclosporin on Pharmacokinetics of Simvastatin
- Registration Number
- NCT05306379
- Lead Sponsor
- Aurinia Pharmaceuticals Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- Written informed consent
- Healthy male or female subjects aged >=18 and <=55 years
- Body mass index >=18.0 and <32 kg/m2
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Voclosporin/Simvastatin Simvastatin 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. Voclosporin/Simvastatin Voclosporin 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.
- Primary Outcome Measures
Name Time Method Pharmacokinetics of simvastatin and simvastatin acid (Cmax) 9 days To evaluate the potential effect of multiple oral doses of voclosporin on the single-dose PK of simvastatin and the active metabolite simvastatin acid. Maximum observed concentration (Cmax).
Pharmacokinetics of simvastatin and simvastatin acid (AUC) 9 days To evaluate the potential effect of multiple oral doses of voclosporin on the single-dose PK of simvastatin and the active metabolite simvastatin acid. Area under the concentration-time curve (AUC) time zero to last quantifiable concentration.
- Secondary Outcome Measures
Name Time Method Pharmacokinetics of voclosporin (Cmax) 9 days To evaluate voclosporin blood concentrations - Cmax.
Pharmacokinetics of voclosporin (Tmax) 9 days To evaluate voclosporin blood concentrations - Time to reach maximum observed plasma concentration (Tmax).
Pharmacokinetics of voclosporin (AUC) 9 days To evaluate voclosporin blood concentrations - AUC from time zero to 12 hours.
Number of participants with abnormal laboratory test results Up to 2 weeks Number of subjects with abnormal laboratory test results (eg., hematology, biochemistry and urinalysis) will be assessed
12-Lead Electrocardiogram Assessment Up to 2 weeks Standard 12-lead electrocardiograms (eg., QTcF interval) will be summarized by observed value and change from baseline values.
Pharmacokinetics of voclosporin (Ctrough) 9 days To evaluate voclosporin blood concentrations - Trough concentration (Ctrough) at the end of a dosing interval at steady state.
Pharmacokinetics of voclosporin (CL/F) 9 days To evaluate voclosporin blood concentrations - apparent clearance (CL/F).
Number of participants with abnormal vital signs Up to 2 weeks Number of participants with abnormal vital signs (eg., blood pressure, heart rate, body temperature, respiratory rate) will be assessed
Trial Locations
- Locations (1)
Labcorp Clinical Research Unit
🇺🇸Dallas, Texas, United States