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Evaluation of Safety and Pharmacokinetics of Single Doses of VBY-376 in Healthy Adults | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

A Randomized, Double-blinded, Placebo-controlled, Sequential, Single Ascending Dose Evaluation of the Safety and Pharmacokinetics of VBY-376 in Healthy Adults

NCT00557583•Virobay Inc.

View on ClinicalTrials.gov

Summary

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

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

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

Locations (1)

Covance Clinical Research Unit

Madison, Wisconsin, United States

Key Dates

Start Date

November 1, 2007

Primary Completion Date

February 1, 2008

Completion Date

February 1, 2008

Last Updated

December 31, 2013

Enrollment

ACTUAL participants

Conditions

Chronic Hepatitis C Infection

Interventions

VBY 376

DRUG

Efficacy and Safety Study of Pegylated Interferon Lambda-1a With Ribavirin and Daclatasvir, to Treat naïve Subjects With Chronic HCV Genotypes 1, 2, 3, and 4 Who Are Co-infected With HIV

NCT01866930

Chronic Hepatitis C Infection

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COMPLETED

Efficacy and Safety of Therapy Against HCV Based on Direct-acting Antivirals in Real-life Conditions

NCT02333292

Chronic Hepatitis C Infection

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COMPLETEDPHASE3

A Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267; (ABT-267 Also Known as Ombitasvir) and ABT-333 (Also Known as Dasabuvir) Coadministered With Ribavirin (RBV) in Hepatitis C Virus (HCV) Genotype 1-infected Adults With Compensated Cirrhosis

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: March 29, 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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Evaluation of Safety and Pharmacokinetics of Single Doses of VBY-376 in Healthy Adults

Inclusion Criteria

Exclusion Criteria

Efficacy and Safety Study of Pegylated Interferon Lambda-1a With Ribavirin and Daclatasvir, to Treat naïve Subjects With Chronic HCV Genotypes 1, 2, 3, and 4 Who Are Co-infected With HIV

Efficacy and Safety of Therapy Against HCV Based on Direct-acting Antivirals in Real-life Conditions

A Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267; (ABT-267 Also Known as Ombitasvir) and ABT-333 (Also Known as Dasabuvir) Coadministered With Ribavirin (RBV) in Hepatitis C Virus (HCV) Genotype 1-infected Adults With Compensated Cirrhosis

A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis

Assess the Antifibrotic Activity of Fuzheng Huayu in Chronic Hepatitis C Patients With Hepatic Fibrosis

Study to Assess the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of ABT-267 in HCV Infected Subjects