Chronic Hepatitis C InfectionPhase 1NCT00557583
Evaluation of Safety and Pharmacokinetics of Single Doses of VBY-376 in Healthy Adults
A Phase 1 study testing VBY 376 in people with Chronic Hepatitis C Infection, run by Virobay Inc. at 1 site in United States.
Trial summary
The study will evaluate the safety and pharmacokinetics of single doses of VBY-376 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis C Infection
- What is being tested?
- VBY 376
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Feb 2008
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- males and females between 18 and 45 years of age
- screening body mass index between 20 and 29 kg/m2
- in good health with no clinically significant medical conditions
- able to comprehend and willing to sign an informed consent
Who cannot join
- history of renal, hepatic impairment, stomach or intestinal surgery or resection, malabsorption syndrome
- anemia or blood donation within 8 weeks of check-in
- plasma donation within 4 weeks of check-in
- history of alcoholism or drug addiction within 1 year prior to check-in
- use of drugs of abuse
- no tobacco-containing products within 6 months of study
Show all 10Show fewer
- participation of any clinical trial within 30 days
- history or presence of abnormal ECG
- no prescription or over-the-counter medications within 14 days of study and during the study
- history of Gilbert's syndrome
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit
Madison, Wisconsin, 53704
About this study
Official title: A Randomized, Double-blinded, Placebo-controlled, Sequential, Single Ascending Dose Evaluation of the Safety and Pharmacokinetics of VBY-376 in Healthy Adults
The study will evaluate the safety and pharmacokinetics of single doses of VBY-376 in healthy subjects.
Read the detailed description
Single dose escalation study of 5 dose levels of VBY-376. Eight subjects per group will receive one dose of VBY-376 then have multiple blood draws for pharmacokinetic evaluation and followed for safety with laboratory evaluations, ECG's, vital signs, and adverse events. Safety data will be reviewed before proceeding to the next dose.
- Conditions
- Chronic Hepatitis C Infection
- Being tested
- VBY 376
- Keywords
- VBY-376 Hepatitis C pharmacokinetics safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VBY 376Drug
Doses of 50mg and higher or placebo will be evaluated.
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of VBY-376 in single oral doses in healthy subjects.
Measured: 7 days
Secondary outcomes (1)
To evaluate the pharmacokinetics of VBY-376 after single oral doses and the effect of food on VBY-376.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis C InfectionStudies 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virobay Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen D Flach, MD, Principal investigator, Covance CRU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00557583
- Sponsor's protocol ID
- VBY-376-001
- Status last verified
- Dec 2013
- First submitted
- 12 Nov 2007
- Last updated
- 31 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
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 Randomized, Double-blinded, Placebo-controlled, Sequential, Single Ascending Dose Evaluation of the Safety and Pharmacokinetics of VBY-376 in Healthy Adults
- ClinicalTrials.gov ID
- NCT00557583
- Acronym / sponsor ID
- VBY-376-001
- Conditions
- Chronic Hepatitis C Infection
- Keywords
- VBY-376 Hepatitis C pharmacokinetics safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Virobay Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 14 Nov 2007 (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.
The study will evaluate the safety and pharmacokinetics of single doses of VBY-376 in healthy subjects.
Detailed description
Single dose escalation study of 5 dose levels of VBY-376. Eight subjects per group will receive one dose of VBY-376 then have multiple blood draws for pharmacokinetic evaluation and followed for safety with laboratory evaluations, ECG's, vital signs, and adverse events. Safety data will be reviewed before proceeding to the next dose.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- males and females between 18 and 45 years of age
- screening body mass index between 20 and 29 kg/m2
- in good health with no clinically significant medical conditions
- able to comprehend and willing to sign an informed consent
Key exclusion criteria (10 listed)
- history of renal, hepatic impairment, stomach or intestinal surgery or resection, malabsorption syndrome
- anemia or blood donation within 8 weeks of check-in
- plasma donation within 4 weeks of check-in
- history of alcoholism or drug addiction within 1 year prior to check-in
- use of drugs of abuse
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 376Doses of 50mg and higher or placebo will be evaluated. | Drug | – |
Primary outcome
To evaluate the safety of VBY-376 in single oral doses in healthy subjects.
Time frame: 7 days
1 secondary outcome
To evaluate the pharmacokinetics of VBY-376 after single oral doses and the effect of food on VBY-376.
Time frame: 7 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.
- Sponsor websiteLink provided by the sponsor.
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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.
Stephen D Flach, MD principal investigator
Covance CRU
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 376 in people with Chronic Hepatitis C Infection, 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 4 inclusion and 10 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. 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?
To evaluate the safety of VBY-376 in single oral doses in healthy subjects. (time frame: 7 days). 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.