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

NCT00557583 | Completed Phase 1

• 1 other identifier: VBY-376-001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Hepatitis C Infection

Keywords

VBY-376 Hepatitis C pharmacokinetics safety

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety of VBY-376 in single oral doses in healthy subjects.

  7 days

Secondary Outcomes (1)

• To evaluate the pharmacokinetics of VBY-376 after single oral doses and the effect of food on VBY-376.

  7 days

Interventions

VBY 376 DRUG

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virobay Inc.: lead

Study Sites (1)

Covance Clinical Research Unit

Madison, Wisconsin, 53704, United States

Location

Related Links

• Sponsor website

Study Officials

• Stephen D Flach, MD

  Covance CRU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2007
• First Posted: November 14, 2007
• Study Start: November 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: December 31, 2013

Record last verified: 2013-12

Locations

US (1)