Drug-drug InteractionPhase 1Statin-DDINCT05306379
Drug-Drug Interaction Study to Investigate Effects of Voclosporin on Pharmacokinetics of Simvastatin
A Phase 1 study testing Simvastatin and Voclosporin in people with Drug-drug Interaction, run by Aurinia Pharmaceuticals Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug-drug Interaction
- What is being tested?
- Simvastatin and Voclosporin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2022to 5 Apr 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent
- Healthy male or female subjects aged >=18 and <=55 years
- Body mass index >=18.0 and <32 kg/m2
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Simvastatin, Voclosporin
- Keywords
- voclosporin, simvastatin, pharmacokinetics, drug effects, drug interactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimvastatinDrug
Oral dose 40 mg
VoclosporinDrug
Oral dose 23.7 mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Simvastatin; Drug: Voclosporin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 9 days
Secondary outcomes (8)
Pharmacokinetics of voclosporin (Cmax)
To evaluate voclosporin blood concentrations - Cmax.
Measured: 9 days
Pharmacokinetics of voclosporin (AUC)
To evaluate voclosporin blood concentrations - AUC from time zero to 12 hours.
Measured: 9 days
Pharmacokinetics of voclosporin (Tmax)
To evaluate voclosporin blood concentrations - Time to reach maximum observed plasma concentration (Tmax).
Measured: 9 days
Pharmacokinetics of voclosporin (Ctrough)
To evaluate voclosporin blood concentrations - Trough concentration (Ctrough) at the end of a dosing interval at steady state.
Measured: 9 days
Pharmacokinetics of voclosporin (CL/F)
To evaluate voclosporin blood concentrations - apparent clearance (CL/F).
Measured: 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
Measured: 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
Measured: 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.
Measured: Up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start24 Jan 2022
- Primary completion5 Apr 2022
- Study completion5 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-drug InteractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aurinia Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Winnie Lim, Study director, Aurinia Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05306379
- Sponsor's protocol ID
- AUR-VCS-2021-02
- Acronym
- Statin-DDI
- Status last verified
- Apr 2022
- First submitted
- 7 Feb 2022
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05306379
- Acronym / sponsor ID
- Statin-DDI / AUR-VCS-2021-02
- Conditions
- Drug-drug Interaction
- Keywords
- voclosporin, simvastatin, pharmacokinetics, drug effects, drug interactions
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Aurinia Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 5 Apr 2022 (actual)
- Study completion
- 5 Apr 2022 (actual)
- First posted
- 1 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Voclosporin/Simvastatin | Experimental | Drug: Simvastatin, Drug: VoclosporinSubjects 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Written informed consent
- Healthy male or female subjects aged >=18 and <=55 years
- Body mass index >=18.0 and <32 kg/m2
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SimvastatinOral dose 40 mg | Drug | Voclosporin/Simvastatin |
| VoclosporinOral dose 23.7 mg twice daily | Drug | Voclosporin/Simvastatin |
Primary outcome
Pharmacokinetics of simvastatin and simvastatin acid (Cmax)
Time frame: 9 days
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).
Pharmacokinetics of simvastatin and simvastatin acid (AUC)
Time frame: 9 days
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.
Pharmacokinetics of simvastatin and simvastatin acid (AUC)
Time frame: 9 days
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.
8 secondary outcomes
Pharmacokinetics of voclosporin (Cmax)
Time frame: 9 days
Pharmacokinetics of voclosporin (AUC)
Time frame: 9 days
Pharmacokinetics of voclosporin (Tmax)
Time frame: 9 days
Pharmacokinetics of voclosporin (Ctrough)
Time frame: 9 days
Pharmacokinetics of voclosporin (CL/F)
Time frame: 9 days
Number of participants with abnormal laboratory test results
Time frame: Up to 2 weeks
Number of participants with abnormal vital signs
Time frame: Up to 2 weeks
12-Lead Electrocardiogram Assessment
Time frame: Up to 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Winnie Lim study director
Aurinia Pharmaceuticals Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Simvastatin and Voclosporin in people with Drug-drug Interaction, run by Aurinia Pharmaceuticals Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics of simvastatin and simvastatin acid (Cmax) (time frame: 9 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.