Drug-drug Interaction
Conditions
Keywords
voclosporin, simvastatin, pharmacokinetics, drug effects, drug interactions
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.
Interventions
DRUGSimvastatin
Oral dose 40 mg
DRUGVoclosporin
Oral dose 23.7 mg twice daily
Sponsors
Aurinia Pharmaceuticals Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) from time zero to infinity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of voclosporin (Tmax) | 9 days | To evaluate voclosporin blood concentrations - Time to reach maximum observed plasma concentration (Tmax). |
| 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). |
| Pharmacokinetics of voclosporin (Cmax) | 9 days | To evaluate voclosporin blood concentrations - Cmax. |
| 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 |
| 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. |
| 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 |
| Pharmacokinetics of voclosporin (AUC) | 9 days | To evaluate voclosporin blood concentrations - AUC from time zero to 12 hours. |
Countries
United States
Outcome results
None listed