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Voclosporin in Healthy Japanese Volunteers

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ClinicalTrials.gov Identifier: NCT02949999
Recruitment Status : Completed
First Posted : October 31, 2016
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Aurinia Pharmaceuticals Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Volunteers Drug: Voclosporin Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : October 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: 0.25mg/kg voclosporin
0.25mg/kg voclosporin BID.
Drug: Voclosporin
Other Name: ISA247

Experimental: 0.5mg/kg voclosporin
0.5mg/kg voclosporin BID
Drug: Voclosporin
Other Name: ISA247

Experimental: 1.0mg/kg voclosporin
1.0mg/kg voclosporin BID
Drug: Voclosporin
Other Name: ISA247

Experimental: 1.5mg/kg voclosporin
1.5mg/kg voclosporin BID
Drug: Voclosporin
Other Name: ISA247

Placebo Comparator: Placebo voclosporin
placebo BID
Drug: Voclosporin
Other Name: ISA247




Primary Outcome Measures :
  1. Incidence of treatment emergent adverse events [ Time Frame: 21 days ]
    Tolerability of voclosporin after single and multiple oral ascending doses

  2. 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


Secondary Outcome Measures :
  1. Pharmacokinetics of voclosporin after single and multiple oral ascending doses [ Time Frame: 21 days ]
    Peak Plasma Concentration (Cmax)

  2. Pharmacokinetics of voclosporin after single and multiple oral ascending doses [ Time Frame: 21 days ]
    Area under the plasma concentration versus time curve (AUC)



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02949999


Locations
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Philippines
MAD VCS Site
Dasmarinas City, Cavite, Philippines
Sponsors and Collaborators
Aurinia Pharmaceuticals Inc.

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Responsible Party: Aurinia Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT02949999     History of Changes
Other Study ID Numbers: AUR-VCS-2015-J01
First Posted: October 31, 2016    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Aurinia Pharmaceuticals Inc.:
Calcineurin inhibitor
Voclosporin

Additional relevant MeSH terms:
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Cyclosporine
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Calcineurin Inhibitors