VolunteersPhase 1NCT02949999
Voclosporin in Healthy Japanese Volunteers
A Phase 1 study testing Voclosporin in people with Volunteers, run by Aurinia Pharmaceuticals Inc. at 1 site in Philippines.
Trial summary
The study is a single-centre, double-blind, placebo controlled, randomized, ascending multiple dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamic profiles of voclosporin. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Volunteers
- What is being tested?
- Voclosporin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 sitePhilippines
- Study dates
- Oct 2016to Dec 2016
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Japanese males and females by birth aged 20 - 45 years inclusive
- Females who are non-pregnant, non-lactating, and either post-menopausal for at least 1 year, surgically sterile for at least 3 months, or from 35 days prior to study entry (i.e. Day -2) until 30 days following study completion/discharge and using an approved method of contraception.
- Males who are sterile or from the time of dose administration until 30 days following their dose administration and using an approved method of contraception.
- Screening FSH >40 IU/ml in self-identified post-menopausal female subjects.
- Weight must be >55 kg but <100 kg, with BMI of 18-30 kg/m2 inclusive.
- Healthy as defined by normal screening assessments, including full medical history, complete physical examination, vital signs, 12-lead ECG, hematology, blood chemistry and urinalysis. Laboratory results must be within the reference range or considered to be not clinically significant by the Principal Investigator with agreement of the Medical Monitor. Lab tests may be repeated during the screening period as appropriate.
- Capable to participate, provide informed consent and comply with study procedures and restrictions
- Must agree to refrain from consumption of grapefruit juice from at least one week prior to dosing until all follow-up procedures are completed.
Who cannot join
- History of drug abuse and/or alcoholism in the previous 2 years.
- Positive urine drug test, urine cotinine test or alcohol breath test at screening.
- Positive for Hepatitis B, Hepatitis C or HIV.
- QTcB >430 msec in males, or QTcB >450 msec in females in 12-lead ECG tracing at screening.
- Blood donation within 56 days prior to dosing and plasma donation within 7 days prior to first dosing.
- Hemoglobin value < 12 g/dL.
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- Current smokers (smoking cigarettes and other forms of tobacco or nicotine use must be stopped at least 90 days before screening).
- History of alcohol consumption averaging more than 2 drinks per day in a week (1 drink is 12 oz beer, 4 oz wine or 1.5oz of spirits) within 6 months prior to screening. Alcohol-containing foods or beverages are prohibited within 7 days prior to study entry and during the entire study duration.
- Use of any drugs known to inhibit or induce hepatic drug metabolism (i.e. inducers include barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin; inhibitors include antidepressants, cimetidine, diltiazem, erythromycin, ketoconazole, MAO inhibitors, neuroleptics, verapamil, quinidine) within 30 days prior to administration of the study medication.
- Participation in a clinical trial involving the administration of an investigational or marketed drug within 30 days (90 days for biologics) prior to the first dosing
- Use of prescription medication within 14 days prior to first dosing or over-the-counter products (including natural products, vitamins, garlic as supplement) within 7 days prior to first dosing, except for topical products without systemic absorption, or is likely to need medication during the study period.
- Clinically significant abnormal liver function, abnormal renal function, active tuberculosis (TB), or known history of TB/evidence of old TB if not taking prophylaxis with isoniazid, current or recent infections, history of hypertension and history of malignancy.
- Any reason which, in the opinion of the Principal Investigator or the Sponsor's medical monitor, would prevent the subject from participating in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Double-blind, Placebo-controlled, Randomized, Ascending Multiple-dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of Voclosporin in Healthy Japanese Volunteers
The study is a single-centre, double-blind, placebo controlled, randomized, ascending multiple dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamic profiles of voclosporin.
Read the detailed description
Ten subjects will be randomized into each of four treatment groups to receive approximately 0.25, 0.5, 1.0, 1.5mg/kg/dose of voclosporin vs placebo. For Day 1, subjects will be given oral treatment once a day; Day 2, subjects will not be given any oral treatment; Day 3-12, subjects will be given oral treatment twice a day; Day 13, subjects will be given oral treatment once a day. The duration of the study takes about 21 days (including follow up assessments).
- Conditions
- Volunteers
- Being tested
- Voclosporin
- Keywords
- Calcineurin inhibitor, Voclosporin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VoclosporinDrug
Also called ISA247
| Study group | Role | What they receive |
|---|---|---|
| 0.25mg/kg voclosporin | Experimental | 0.25mg/kg voclosporin BID. Receives: Drug: Voclosporin |
| 0.5mg/kg voclosporin | Experimental | 0.5mg/kg voclosporin BID Receives: Drug: Voclosporin |
| 1.0mg/kg voclosporin | Experimental | 1.0mg/kg voclosporin BID Receives: Drug: Voclosporin |
| 1.5mg/kg voclosporin | Experimental | 1.5mg/kg voclosporin BID Receives: Drug: Voclosporin |
| Placebo voclosporin | Placebo comparator | placebo BID Receives: Drug: Voclosporin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events
Tolerability of voclosporin after single and multiple oral ascending doses
Measured: 21 days
Mean, median and standard deviation of laboratory parameters. Incidence of laboratory parameters outside of normal range
Safety of voclosporin after single and multiple oral ascending doses
Measured: 21 days
Secondary outcomes (2)
Pharmacokinetics of voclosporin after single and multiple oral ascending doses
Peak Plasma Concentration (Cmax)
Measured: 21 days
Pharmacokinetics of voclosporin after single and multiple oral ascending doses
Area under the plasma concentration versus time curve (AUC)
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VolunteersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aurinia Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02949999
- Sponsor's protocol ID
- AUR-VCS-2015-J01
- Status last verified
- Jan 2018
- First submitted
- 20 Oct 2016
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Double-blind, Placebo-controlled, Randomized, Ascending Multiple-dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of Voclosporin in Healthy Japanese Volunteers
- ClinicalTrials.gov ID
- NCT02949999
- Acronym / sponsor ID
- AUR-VCS-2015-J01
- Conditions
- Volunteers
- Keywords
- Calcineurin inhibitor, Voclosporin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aurinia Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 31 Oct 2016 (estimated)
- 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.
The study is a single-centre, double-blind, placebo controlled, randomized, ascending multiple dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamic profiles of voclosporin.
Detailed description
Ten subjects will be randomized into each of four treatment groups to receive approximately 0.25, 0.5, 1.0, 1.5mg/kg/dose of voclosporin vs placebo. For Day 1, subjects will be given oral treatment once a day; Day 2, subjects will not be given any oral treatment; Day 3-12, subjects will be given oral treatment twice a day; Day 13, subjects will be given oral treatment once a day. The duration of the study takes about 21 days (including follow up assessments).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 0.25mg/kg voclosporin | Experimental | Drug: Voclosporin0.25mg/kg voclosporin BID. |
| 0.5mg/kg voclosporin | Experimental | Drug: Voclosporin0.5mg/kg voclosporin BID |
| 1.0mg/kg voclosporin | Experimental | Drug: Voclosporin1.0mg/kg voclosporin BID |
| 1.5mg/kg voclosporin | Experimental | Drug: Voclosporin1.5mg/kg voclosporin BID |
| Placebo voclosporin | Placebo comparator | Drug: Voclosporinplacebo BID |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Japanese males and females by birth aged 20 - 45 years inclusive
- Females who are non-pregnant, non-lactating, and either post-menopausal for at least 1 year, surgically sterile for at least 3 months, or from 35 days prior to study entry (i.e. Day -2) until 30 days following study completion/discharge and using an approved method of contraception.
- Males who are sterile or from the time of dose administration until 30 days following their dose administration and using an approved method of contraception.
- Screening FSH >40 IU/ml in self-identified post-menopausal female subjects.
- Weight must be >55 kg but <100 kg, with BMI of 18-30 kg/m2 inclusive.
Key exclusion criteria (13 listed)
- History of drug abuse and/or alcoholism in the previous 2 years.
- Positive urine drug test, urine cotinine test or alcohol breath test at screening.
- Positive for Hepatitis B, Hepatitis C or HIV.
- QTcB >430 msec in males, or QTcB >450 msec in females in 12-lead ECG tracing at screening.
- Blood donation within 56 days prior to dosing and plasma donation within 7 days prior to first dosing.
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 |
|---|---|---|
| VoclosporinAlso: ISA247 | Drug | 0.25mg/kg voclosporin, 0.5mg/kg voclosporin, 1.0mg/kg voclosporin, 1.5mg/kg voclosporin, Placebo voclosporin |
Primary outcome
Incidence of treatment emergent adverse events
Time frame: 21 days
Tolerability of voclosporin after single and multiple oral ascending doses
Mean, median and standard deviation of laboratory parameters. Incidence of laboratory parameters outside of normal range
Time frame: 21 days
Safety of voclosporin after single and multiple oral ascending doses
2 secondary outcomes
Pharmacokinetics of voclosporin after single and multiple oral ascending doses
Time frame: 21 days
Pharmacokinetics of voclosporin after single and multiple oral ascending doses
Time frame: 21 days
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 17 Jan 2018.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Voclosporin in people with Volunteers, run by Aurinia Pharmaceuticals Inc. at 1 site in Philippines.
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 8 inclusion and 13 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 17 Jan 2018. 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 Philippines. 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. Some participants in this study may receive a placebo. 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?
Incidence of treatment emergent adverse events (time frame: 21 days). The study lists 2 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 17 Jan 2018.