Healthy
Conditions
Keywords
Healthy, Subjects, Safety, Tolerability, VBY-036, Maximum, Pharmacodynamic, Pharmacokinetic
Brief summary
VBY-036 may treat or prevent nerve pain. This study aims to find the highest safe and tolerable single dose of VBY-036 in healthy volunteers. Volunteers are randomly selected to receive one dose of either a placebo or VBY-036 (10, 30, 100, 300, 600 or 900 mg).
Detailed description
Detailed description is noted in Brief Summary.
Interventions
DRUGVBY-036
Study drug VBY-036
DRUGPlacebo
Placebo
Sponsors
Virobay Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female, 18-60 years old * Screening body mass index between 18-32 kg/m2 * Good health, no clinically significant findings in medical history, 12-lead ECG, & vital signs; * Clinical lab evaluations (Chem panel \[fasted at least 8 hrs\], CBC, HbA1c & UA in reference range for test lab (unless deemed not clinically significant); * Negative test for drugs of abuse at Screening & at Check-in (includes alcohol); * Negative hepatitis, HIV & TB screens; * Females non-pregnant, non-lactating, & either postmenopausal for at least 1 year, surgically sterile for at least 90 days prior to Check-in, or agree to use from the time of consent until 90 days after Study Completion an effective form of contraception. For all females, a pregnancy test result must be negative at Screening & Check-in. * Males will be sterile or agree to use from Check-in until 90 days following discharge an effective method of contraception. * Able to comprehend & willing to sign Informed Consent Form
Exclusion criteria
* Females pregnant or nursing, or childbearing potential but unwilling to use contraception. * History of renal or hepatic impairment; stomach or intestinal surgery or resection, malabsorption syndrome, cholecystectomy, or gastro-intestinal dysfunction that would alter absorption &/or excretion of orally administered drugs (appendectomy or hernia repair allowed); * Anemia (hemoglobin \<11.5 g/dL for females; \< 13 g/dL for males) or blood donation within 8 weeks of Check-in; * Plasma donation within 4 weeks of Check-in; * History of alcoholism or drug addiction within 6 months to Check-in; * Use of drugs of abuse or prescription drugs for recreational use 6 months prior to Check-in; * Use of any tobacco-containing or nicotine-containing products 6 months prior to Check-in & during study; * Participation in another drug trial 30 days of Check-in (within 8 weeks if previous investigational drug has immunomodulary effects, other than cathepsin S inhibition); * History or clinical manifestations of metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, or psychiatric disorders * History of hypersensitivity or allergies to any drug compound * History or presence of abnormal ECG * Laboratory abnormality deemed clinically significant; * Use of or inability to discontinue any prescription medications/products 14 days prior to Check-in & during study; * Use of certain over-the-counter, non-prescription preparations are permitted up to 3 days before first dose; * Use of alcohol-containing, grapefruit-containing, star fruit containing foods or beverages or energy drinks 72 hours to Check-in & during study; * Poor peripheral venous access; * Receipt of blood products 6 months to Check-in * Subjects with history of Gilbert's Syndrome; * Strenuous activities 48 hours before receiving experimental or placebo comparator * Illness 5 days to drug administration * Any acute or chronic condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Highest safe and tolerated VBY-036 dose | 5-days assessment | Single dose of VBY-036 given one day for each cohort in an ascending manner. Cohort A1 with 10 mg dose or placebo; Cohort A2 with 30 mg dose or placebo; Cohort A3 with 100 mg dose or placebo; Cohort A4 with 300 mg dose or placebo; Cohort A5 with 600 mg dose or placebo; Cohort A6 with 900 mg dose or placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Confirmation of cathepsin-S inhibition | 2 days | Based on the accumulation of Iip 10 and/or cathepsin S protein levels |
Other
| Measure | Time frame | Description |
|---|---|---|
| The blood level of VBY-036 | 4 days | The blood level of VBY-036 across the dose range of 10 mg to 900 mg |
Countries
United States
Outcome results
None listed