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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
24
Oral dose 40 mg
Oral dose 23.7 mg twice daily
Labcorp Clinical Research Unit
Dallas, Texas, United States
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).
Time frame: 9 days
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.
Time frame: 9 days
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.
Time frame: 9 days
Pharmacokinetics of voclosporin (Cmax)
To evaluate voclosporin blood concentrations - Cmax.
Time frame: 9 days
Pharmacokinetics of voclosporin (AUC)
To evaluate voclosporin blood concentrations - AUC from time zero to 12 hours.
Time frame: 9 days
Pharmacokinetics of voclosporin (Tmax)
To evaluate voclosporin blood concentrations - Time to reach maximum observed plasma concentration (Tmax).
Time frame: 9 days
Pharmacokinetics of voclosporin (Ctrough)
To evaluate voclosporin blood concentrations - Trough concentration (Ctrough) at the end of a dosing interval at steady state.
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Time frame: 9 days
Pharmacokinetics of voclosporin (CL/F)
To evaluate voclosporin blood concentrations - apparent clearance (CL/F).
Time frame: 9 days
Number of participants with abnormal laboratory test results
Number of subjects with abnormal laboratory test results (eg., hematology, biochemistry and urinalysis) will be assessed
Time frame: Up to 2 weeks
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
Time frame: Up to 2 weeks
12-Lead Electrocardiogram Assessment
Standard 12-lead electrocardiograms (eg., QTcF interval) will be summarized by observed value and change from baseline values.
Time frame: Up to 2 weeks