Drug-Drug Interaction Study to Investigate Effects of Voclosporin on Pharmacokinetics of Simvastatin

Drug-drug Interaction Clinical Trial

— Statin-DDI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05306379
• Other study ID #: AUR-VCS-2021-02
• Status: Completed
• Phase: Phase 1
• Start date: January 24, 2022
• Est. completion date: April 5, 2022

Study information

• Verified date: April 2022
• Source: Aurinia Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 5, 2022
• Est. primary completion date: April 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug-drug Interaction

Intervention

Drug:
• Simvastatin
Oral dose 40 mg
• Voclosporin
Oral dose 23.7 mg twice daily

Locations

Country	Name	City	State
United States	Labcorp Clinical Research Unit	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Aurinia Pharmaceuticals Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of simvastatin and simvastatin acid (Cmax)	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).	9 days
Primary	Pharmacokinetics of simvastatin and simvastatin acid (AUC)	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.	9 days
Primary	Pharmacokinetics of simvastatin and simvastatin acid (AUC)	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.	9 days
Secondary	Pharmacokinetics of voclosporin (Cmax)	To evaluate voclosporin blood concentrations - Cmax.	9 days
Secondary	Pharmacokinetics of voclosporin (AUC)	To evaluate voclosporin blood concentrations - AUC from time zero to 12 hours.	9 days
Secondary	Pharmacokinetics of voclosporin (Tmax)	To evaluate voclosporin blood concentrations - Time to reach maximum observed plasma concentration (Tmax).	9 days
Secondary	Pharmacokinetics of voclosporin (Ctrough)	To evaluate voclosporin blood concentrations - Trough concentration (Ctrough) at the end of a dosing interval at steady state.	9 days
Secondary	Pharmacokinetics of voclosporin (CL/F)	To evaluate voclosporin blood concentrations - apparent clearance (CL/F).	9 days
Secondary	Number of participants with abnormal laboratory test results	Number of subjects with abnormal laboratory test results (eg., hematology, biochemistry and urinalysis) will be assessed	Up to 2 weeks
Secondary	Number of participants with abnormal vital signs	Number of participants with abnormal vital signs (eg., blood pressure, heart rate, body temperature, respiratory rate) will be assessed	Up to 2 weeks
Secondary	12-Lead Electrocardiogram Assessment	Standard 12-lead electrocardiograms (eg., QTcF interval) will be summarized by observed value and change from baseline values.	Up to 2 weeks