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

Virobay

Status and phase: Completed; Phase 1

Conditions: Chronic Hepatitis C Infection

Treatments: Drug: VBY 376

Study type: Interventional

Funder types: Industry

Identifiers

NCT00557583

VBY-376-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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