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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01892891
Recruitment Status : Completed
First Posted : July 8, 2013
Last Update Posted : December 31, 2013
Sponsor:
Information provided by (Responsible Party):
Virobay Inc.

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

Condition or disease Intervention/treatment Phase
Healthy Drug: VBY-036 Phase 1

Detailed Description:
Detailed description is noted in Brief Summary.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

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



Primary Outcome Measures :
  1. Highest safe and tolerated VBY-036 dose [ Time Frame: 7 days of dosing ]

    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



Secondary Outcome Measures :
  1. Confirmation of cathepsin-S inhibition [ Time Frame: 7 days ]
    Based on the accumulation of Iip 10 and/or cathepsin S protein levels


Other Outcome Measures:
  1. The blood level of VBY-036 [ Time Frame: 7 days ]
    The blood level of VBY-036 across the dose range of 30 mg to 900 mg



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 to Check-in
  • Illness 5 days to drug administration
  • Any acute or chronic condition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01892891


Locations
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United States, Indiana
Covance Evansville
Evansville, Indiana, United States, 47710
Sponsors and Collaborators
Virobay Inc.
Investigators
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Study Director: David B. Karpf, MD Virobay Inc.

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Responsible Party: Virobay Inc.
ClinicalTrials.gov Identifier: NCT01892891     History of Changes
Other Study ID Numbers: VBY-036-002
First Posted: July 8, 2013    Key Record Dates
Last Update Posted: December 31, 2013
Last Verified: December 2013
Keywords provided by Virobay Inc.:
Healthy
Subjects
Safety
Tolerability
VBY036
maximum
pharmacodynamic
pharmacokinetic