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

This study has been completed.
Information provided by (Responsible Party):
Virobay Inc. Identifier:
First received: November 12, 2007
Last updated: December 27, 2013
Last verified: December 2013
The study will evaluate the safety and pharmacokinetics of single doses of VBY-376 in healthy subjects.

Condition Intervention Phase
Chronic Hepatitis C Infection Drug: VBY 376 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by Virobay Inc.:

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

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

Enrollment: 48
Study Start Date: November 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: VBY 376
    Doses of 50mg and higher or placebo will be evaluated.
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Additional Information:
Responsible Party: Virobay Inc. Identifier: NCT00557583     History of Changes
Other Study ID Numbers: VBY-376-001
Study First Received: November 12, 2007
Last Updated: December 27, 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 processed this record on June 23, 2017