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

NCT05306379 | Completed Phase 1 FDA Drug

• 1 other identifier: AUR-VCS-2021-02
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug-drug Interaction

Keywords

voclosporin; simvastatin; pharmacokinetics; drug effects; drug interactions

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (8)

• Pharmacokinetics of voclosporin (Cmax)

  9 days

• Pharmacokinetics of voclosporin (AUC)

  9 days

• Pharmacokinetics of voclosporin (Tmax)

  9 days

• Pharmacokinetics of voclosporin (Ctrough)

  9 days

• Pharmacokinetics of voclosporin (CL/F)

  9 days

Study Arms (1)

Voclosporin/Simvastatin

EXPERIMENTAL

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.

Drug: Simvastatin; Drug: Voclosporin

Interventions

Simvastatin DRUG

Oral dose 40 mg

Voclosporin/Simvastatin

Voclosporin DRUG

Oral dose 23.7 mg twice daily

Voclosporin/Simvastatin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent
• Healthy male or female subjects aged \>=18 and \<=55 years
• Body mass index \>=18.0 and \<32 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Aurinia Pharmaceuticals Inc.: lead

Study Sites (1)

Labcorp Clinical Research Unit

Dallas, Texas, 75247, United States

Location

MeSH Terms

Interventions

Simvastatin; voclosporin

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Winnie Lim

  Aurinia Pharmaceuticals Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: April 1, 2022
• Study Start: January 24, 2022
• Primary Completion: April 5, 2022
• Study Completion: April 5, 2022
• Last Updated: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)