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

A Double-Blind, Randomized, Placebo-Controlled, Sequential, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Doses of VBY-036 in Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: VBY-036

Detailed Description

Detailed description is noted in Brief Summary.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Evansville, Indiana, United States, 47710
      • Covance Evansville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VBY-036; VBY-036 30 mg, 100 mg, 300 mg, 600 mg, or 900 mg	Drug: VBY-036; Cathepsin S inhibitor
Placebo Comparator: Placebo comparator; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Highest safe and tolerated VBY-036 dose	Single dose of VBY-036 given daily for 7-days in a row for each cohort in an ascending manner. Cohort B1 with 30 mg dose or placebo; Cohort B2 with 100 mg dose or placebo; Cohort B3 with 300 mg dose or placebo; Cohort B4 with 600 mg dose or placebo; Cohort B5 with 900 mg dose or placebo	7 days of dosing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Confirmation of cathepsin-S inhibition	Based on the accumulation of Iip 10 and/or cathepsin S protein levels	7 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The blood level of VBY-036	The blood level of VBY-036 across the dose range of 30 mg to 900 mg	7 days

Collaborators and Investigators

• Sponsor: Virobay Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: July 1, 2013
• First Submitted That Met QC Criteria: July 1, 2013
• First Posted (Estimate): July 8, 2013

Study Record Updates

• Last Update Posted (Estimate): December 31, 2013
• Last Update Submitted That Met QC Criteria: December 27, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Safety; Healthy; Subjects; pharmacokinetic; Tolerability; pharmacodynamic; VBY036; maximum
• Other Study ID Numbers: VBY-036-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No