Voclosporin in Healthy Japanese Volunteers

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02949999
• Date of registration: 20/10/2016
• Prospective Registration: No
• Primary sponsor: Aurinia Pharmaceuticals Inc.
• Public title: Voclosporin in Healthy Japanese Volunteers
• Scientific title: A Single-center, Double-blind, Placebo-controlled, Randomized, Ascending Multiple-dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of Voclosporin in Healthy Japanese Volunteers
• Date of first enrolment: October 2016
• Target sample size: 40
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02949999
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

Philippines

Key inclusion & exclusion 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.



Age minimum: 20 Years
Age maximum: 45 Years
Gender: All

Health Condition(s) or Problem(s) studied

Volunteers

Intervention(s)

Drug: Voclosporin

Primary Outcome(s)

Incidence of treatment emergent adverse events [Time Frame: 21 days]

Mean, median and standard deviation of laboratory parameters. Incidence of laboratory parameters outside of normal range [Time Frame: 21 days]

Secondary Outcome(s)

Pharmacokinetics of voclosporin after single and multiple oral ascending doses [Time Frame: 21 days]

Secondary ID(s)

AUR-VCS-2015-J01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors