HealthyPhase 1NCT01911637
Safety Study of Single Oral Doses of VBY-036 in Healthy Volunteers (VBY036P1A)
A Phase 1 study testing VBY-036 in people with Healthy, run by Virobay Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- VBY-036
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Jul 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
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- 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
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled, Sequential, Single 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 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).
Read the detailed description
Detailed description is noted in Brief Summary.
- Conditions
- Healthy
- Being tested
- VBY-036, Placebo
- Keywords
- Healthy, Subjects, Safety, Tolerability, VBY-036, Maximum, Pharmacodynamic, Pharmacokinetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VBY-036Drug
Also called Cathepsin S inhibitor
Study drug VBY-036
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| VBY-036 | Experimental | VBY-036 10 mg, 30 mg, 100 mg, 300 mg, 600 mg, or 900 mg Receives: Drug: VBY-036; Drug: Placebo |
| Placebo | Placebo comparator | Placebo Receives: Drug: VBY-036; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Highest safe and tolerated VBY-036 dose
Single dose of VBY-036 given one day for each cohort in an ascending manner.
Cohort A1 with 10 mg dose or placebo; Cohort A2 with 30 mg dose or placebo; Cohort A3 with 100 mg dose or placebo; Cohort A4 with 300 mg dose or placebo; Cohort A5 with 600 mg dose or placebo; Cohort A6 with 900 mg dose or placebo
Measured: 5-days assessment
Secondary outcomes (1)
Confirmation of cathepsin-S inhibition
Based on the accumulation of Iip 10 and/or cathepsin S protein levels
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startMay 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virobay Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David B. Karpf, MD, Study director, Virobay Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01911637
- Sponsor's protocol ID
- VBY-036-001
- Status last verified
- Dec 2013
- First submitted
- 12 Jul 2013
- Last updated
- 31 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled, Sequential, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Doses of VBY-036 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01911637
- Acronym / sponsor ID
- VBY-036-001
- Conditions
- Healthy
- Keywords
- Healthy, Subjects, Safety, Tolerability, VBY-036, Maximum, Pharmacodynamic, Pharmacokinetic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Virobay Inc.Industry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 30 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VBY-036 | Experimental | Drug: VBY-036, Drug: PlaceboVBY-036 10 mg, 30 mg, 100 mg, 300 mg, 600 mg, or 900 mg |
| Placebo | Placebo comparator | Drug: VBY-036, Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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);
Key exclusion criteria (21 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VBY-036Also: Cathepsin S inhibitorStudy drug VBY-036 | Drug | Placebo, VBY-036 |
| PlaceboPlacebo | Drug | Placebo, VBY-036 |
Primary outcome
Highest safe and tolerated VBY-036 dose
Time frame: 5-days assessment
Single dose of VBY-036 given one day for each cohort in an ascending manner. Cohort A1 with 10 mg dose or placebo; Cohort A2 with 30 mg dose or placebo; Cohort A3 with 100 mg dose or placebo; Cohort A4 with 300 mg dose or placebo; Cohort A5 with 600 mg dose or placebo; Cohort A6 with 900 mg dose or placebo
1 secondary outcome
Confirmation of cathepsin-S inhibition
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David B. Karpf, MD study director
Virobay Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VBY-036 in people with Healthy, run by Virobay Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Highest safe and tolerated VBY-036 dose (time frame: 5-days assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2013; AzTrials last refreshed its copy on 8 Nov 2026.