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

Chronic Hepatitis C Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00557583
• Other study ID #: VBY-376-001
• Status: Completed
• Phase: Phase 1
• First received: November 12, 2007
• Last updated: December 27, 2013
• Start date: November 2007
• Est. completion date: February 2008

Study information

• Verified date: December 2013
• Source: Virobay Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Chronic Hepatitis C Infection
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• VBY 376
Doses of 50mg and higher or placebo will be evaluated.

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Virobay Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety of VBY-376 in single oral doses in healthy subjects.		7 days	Yes
Secondary	To evaluate the pharmacokinetics of VBY-376 after single oral doses and the effect of food on VBY-376.		7 days	No

External Links

•   Sponsor website