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

Part of paid clinical trials in Dallas, Texas.

Sponsor
Aurinia Pharmaceuticals Inc.
Study ID
NCT05306379
Phase
PHASE1
Status
Completed

Conditions

  • Drug-drug Interaction

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Simvastatin — DRUG
    Oral dose 40 mg
  • Voclosporin — DRUG
    Oral dose 23.7 mg twice daily

Study Details

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.

Key Dates

Start date
Jan 24, 2022
Status verified
Apr 2022
Primary completion
Apr 5, 2022
Completion
Apr 5, 2022

Study Design

Enrollment
24 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Voclosporin/Simvastatin
    Subjects will receive a single oral dose of 40 mg simvastatin (given as two 20 mg tablets) in the morning of Day 1 and Day 8. Subjects will receive voclosporin administered as an oral 23.7 mg dose (three 7.9 mg capsules) twice-daily for 7 days from the morning of Day 2 until the evening of Day 8.

Primary Outcome Measure

Pharmacokinetics of simvastatin and simvastatin acid (Cmax) [ Time Frame: 9 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Labcorp Clinical Research UnitDallasTexas75247-

Find similar trials in Dallas, TX

By research site
Labcorp Clinical Research Unit· Dallas, TX

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