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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00557583

Enrollment

Registered

2007-11-14

Start date

2007-11-30

Completion date

2008-02-29

Last updated

2013-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C Infection

Keywords

VBY-376 Hepatitis C pharmacokinetics safety

Brief 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.

Interventions

DRUGVBY 376

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026