Evaluation of Safety and Pharmacokinetics of Single Doses of VBY-376 in Healthy Adults
This study has been completed.
Sponsor:
Virobay Inc.
Information provided by:
Virobay Inc.
ClinicalTrials.gov Identifier:
NCT00557583
First received: November 12, 2007
Last updated: July 31, 2008
Last verified: July 2008
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The study will evaluate the safety and pharmacokinetics of single doses of VBY-376 in healthy subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Hepatitis C Infection |
Drug: VBY 376 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator) |
| Official Title: | A Randomized, Double-Blinded, Placebo-Controlled, Sequential, Single Ascending Dose Evaluation of the Safety and Pharmacokinetics of VBY-376 in Healthy Adults |
Resource links provided by NLM:
Further study details as provided by Virobay Inc.:
Primary Outcome Measures:
- To evaluate the safety of VBY-376 in single oral doses in healthy subjects. [ Time Frame: 7 days ]
Secondary Outcome Measures:
- To evaluate the pharmacokinetics of VBY-376 after single oral doses and the effect of food on VBY-376. [ Time Frame: 7 days ]
| Estimated Enrollment: | 48 |
| Study Start Date: | November 2007 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: VBY 376
Doses of 50mg and higher or placebo will be evaluated.
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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Dion Coakley/Vice President Clinical Research, Virobay |
| ClinicalTrials.gov Identifier: | NCT00557583 History of Changes |
| Other Study ID Numbers: | VBY-376-001 |
| Study First Received: | November 12, 2007 |
| Last Updated: | July 31, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Virobay Inc.:
|
VBY-376 Hepatitis C pharmacokinetics safety |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases |
Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections |
ClinicalTrials.gov processed this record on June 18, 2013