Status:
COMPLETED
Safety Study of VBY-036 in Healthy Volunteers After 7 Days of Oral Dosing
Lead Sponsor:
Virobay Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
VBY-036 may treat or prevent nerve pain. This study aims to find the highest safe and tolerable dose of VBY-036 in healthy volunteers. Volunteers will be randomly selected to receive either a placebo ...
Detailed Description
Detailed description is noted in Brief Summary.
Eligibility Criteria
Inclusion
- 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
- 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 to Check-in
- Illness 5 days to drug administration
- Any acute or chronic condition
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01892891
Start Date
July 1 2013
End Date
November 1 2013
Last Update
December 31 2013
Active Locations (1)
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1
Covance Evansville
Evansville, Indiana, United States, 47710