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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Virobay Inc.
ClinicalTrials.gov Identifier:
NCT00557583
First received: November 12, 2007
Last updated: December 27, 2013
Last verified: December 2013
  Purpose

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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT00557583

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

Additional Information:
No publications provided

Responsible Party: Virobay Inc.
ClinicalTrials.gov Identifier: NCT00557583     History of Changes
Other Study ID Numbers: VBY-376-001
Study First Received: November 12, 2007
Last Updated: December 27, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 28, 2014