Status:
COMPLETED
Drug-Drug Interaction Study to Investigate Effects of Voclosporin on Pharmacokinetics of Simvastatin
Lead Sponsor:
Aurinia Pharmaceuticals Inc.
Conditions:
Drug-drug Interaction
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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
- Written informed consent
- Healthy male or female subjects aged \>=18 and \<=55 years
- Body mass index \>=18.0 and \<32 kg/m2
Exclusion
- 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
Key Trial Info
Start Date :
January 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 5 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05306379
Start Date
January 24 2022
End Date
April 5 2022
Last Update
April 20 2022
Active Locations (1)
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1
Labcorp Clinical Research Unit
Dallas, Texas, United States, 75247