Safety Study of Single Oral Doses of VBY-036 in Healthy Volunteers (VBY036P1A)

NCT ID: NCT01911637

Last Updated: 2013-12-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2013-07-31

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.

Conditions

Healthy

Keywords

Healthy; Subjects; Safety; Tolerability; VBY-036; Maximum; Pharmacodynamic; Pharmacokinetic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

VBY-036

VBY-036 10 mg, 30 mg, 100 mg, 300 mg, 600 mg, or 900 mg

Group Type: EXPERIMENTAL

VBY-036

Intervention Type: DRUG

Study drug VBY-036

Placebo

Intervention Type: DRUG

Placebo

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

VBY-036

Intervention Type: DRUG

Study drug VBY-036

Placebo

Intervention Type: DRUG

Placebo

Interventions

VBY-036

Study drug VBY-036

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Other Intervention Names

Cathepsin S inhibitor

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Virobay Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David B. Karpf, MD

Role: STUDY_DIRECTOR

Virobay Inc.

Locations

Covance Evansville

Evansville, Indiana, United States

Countries

United States

Other Identifiers

VBY-036-001

Identifier Type: -

Identifier Source: org_study_id