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COMPLETEDPhase 1NCT00557583

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

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

Lead sponsor: Virobay Inc.•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Virobay Inc.

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.

Age

18 - 45 years

Sex

ALL

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: December 31, 2013Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE1

Enrollment48

Start dateNov 2007

Last updatedDec 31, 2013

Condition

Chronic Hepatitis C Infection

Locations shown

Covance Clinical Research Unit

Madison, Wisconsin

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 31, 2013Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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