MedTrace Logo

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

NCT05306379 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-04-20

No results posted yet for this study

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.

Conditions

  • Drug-drug Interaction

Interventions

DRUG

Simvastatin

Oral dose 40 mg

DRUG

Voclosporin

Oral dose 23.7 mg twice daily

Sponsors & Collaborators

  • Aurinia Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Winnie Lim · Aurinia Pharmaceuticals Inc.

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-24
Primary Completion
2022-04-05
Completion
2022-04-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05306379 on ClinicalTrials.gov