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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-02-29

Brief Summary

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

Detailed Description

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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.

Conditions

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Chronic Hepatitis C Infection

Keywords

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VBY-376 Hepatitis C pharmacokinetics safety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Interventions

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VBY 376

Doses of 50mg and higher or placebo will be evaluated.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephen D Flach, MD

Role: PRINCIPAL_INVESTIGATOR

Covance CRU

Locations

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Covance Clinical Research Unit

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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VBY-376-001

Identifier Type: -

Identifier Source: org_study_id