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

December 27, 2013 updated by: Virobay Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53704
        • Covance Clinical Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the safety of VBY-376 in single oral doses in healthy subjects.
Time Frame: 7 days
7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the pharmacokinetics of VBY-376 after single oral doses and the effect of food on VBY-376.
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virobay Inc.

Investigators

  • Principal Investigator: Stephen D Flach, MD, Covance CRU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

November 12, 2007

First Submitted That Met QC Criteria

November 13, 2007

First Posted (Estimate)

November 14, 2007

Study Record Updates

Last Update Posted (Estimate)

December 31, 2013

Last Update Submitted That Met QC Criteria

December 27, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VBY-376-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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