Safety Study of VBY-036 in Healthy Volunteers After 7 Days of Oral Dosing (VBY036P1B)

Virobay

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: VBY-036

Study type

Interventional

Funder types

Industry

Identifiers

NCT01892891

VBY-036-002

Details and patient eligibility

About

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 or VBY-036 (30, 100, 300, 600 or 900 mg) once daily for seven days in a row.

Full description

Detailed description is noted in Brief Summary.

Enrollment

40 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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 to Check-in
Illness 5 days to drug administration
Any acute or chronic condition