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Evaluation of Safety and Pharmacokinetics of Single Doses of VBY-376 in Healthy Adults

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: NCT00557583
Recruitment Status : Completed
First Posted : November 14, 2007
Last Update Posted : December 31, 2013
Information provided by (Responsible Party):
Virobay Inc.

Brief Summary:
The study will evaluate the safety and pharmacokinetics of single doses of VBY-376 in healthy subjects.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Infection Drug: VBY 376 Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Official Title: A Randomized, Double-blinded, Placebo-controlled, Sequential, Single Ascending Dose Evaluation of the Safety and Pharmacokinetics of VBY-376 in Healthy Adults
Study Start Date : November 2007
Primary Completion Date : February 2008
Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: VBY 376
    Doses of 50mg and higher or placebo will be evaluated.

Primary Outcome Measures :
  1. To evaluate the safety of VBY-376 in single oral doses in healthy subjects. [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. To evaluate the pharmacokinetics of VBY-376 after single oral doses and the effect of food on VBY-376. [ Time Frame: 7 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

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): NCT00557583

United States, Wisconsin
Covance Clinical Research Unit
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Virobay Inc.
Principal Investigator: Stephen D Flach, MD Covance CRU

Additional Information:
Responsible Party: Virobay Inc.
ClinicalTrials.gov Identifier: NCT00557583     History of Changes
Other Study ID Numbers: VBY-376-001
First Posted: November 14, 2007    Key Record Dates
Last Update Posted: December 31, 2013
Last Verified: December 2013

Keywords provided by Virobay Inc.:
VBY-376 Hepatitis C pharmacokinetics safety

Additional relevant MeSH terms:
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections