Clinical trial NCT05306379: Drug-Drug Interaction Study to Investigate Effects of Voclosporin on Pharmacokinetics of Simvastatin
Official title: A Single Center, Open Label, Phase 1 Drug-Drug Interaction Study to Investigate the Effects of Voclosporin on the Pharmacokinetics of Simvastatin in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug-drug Interaction
Keywords: voclosporin
simvastatin
pharmacokinetics
drug effects
drug interactions
Lead sponsor: Aurinia Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2022-04-01
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Pharmacokinetics of simvastatin and simvastatin acid (Cmax)
timeFrame: 9 days
measure: Pharmacokinetics of simvastatin and simvastatin acid (AUC)
timeFrame: 9 days
measure: Pharmacokinetics of simvastatin and simvastatin acid (AUC)
timeFrame: 9 days
Secondary outcomes:
measure: Pharmacokinetics of voclosporin (Cmax)
timeFrame: 9 days
measure: Pharmacokinetics of voclosporin (AUC)
timeFrame: 9 days
measure: Pharmacokinetics of voclosporin (Tmax)
timeFrame: 9 days
measure: Pharmacokinetics of voclosporin (Ctrough)
timeFrame: 9 days
measure: Pharmacokinetics of voclosporin (CL/F)
timeFrame: 9 days
measure: Number of participants with abnormal laboratory test results
timeFrame: Up to 2 weeks
measure: Number of participants with abnormal vital signs
timeFrame: Up to 2 weeks
measure: 12-Lead Electrocardiogram Assessment
timeFrame: Up to 2 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Labcorp Clinical Research Unit
state: Texas
Study officials:
affiliation: Aurinia Pharmaceuticals Inc.
name: Winnie Lim
role: STUDY_DIRECTOR
References: