Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021510-36 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to assess the safety, tolerability, antiviral effects, and pharmacokinetics of PPI-461 in patients with chronic hepatitis C virus genotype 1 infection.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Active Comparator | PPI-461 50 mg or placebo |
|
| Cohort B | Active Comparator | PPI-461 100 mg or placebo |
|
| Cohort C | Active Comparator | PPI-461 200 mg or placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PPI-461 | Drug | capsule, oral, once daily for 3 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability, as measured by clinical adverse events and laboratory assessments | up to Study Day 16 (14 days after the last PPI-461 dose) | |
| Antiviral effects of PPI-461, as measured by HCV RNA levels | Up to Study Day 16 (14 days after the last PPI-461 dose) | |
| PPI-461 pharmacokinetics as measured by plasma PPI-461 concentrations | Up to Study Day 10 (8 days after the last PPI-461 dose) |
Not provided
Not provided
Eligibility Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nathaniel Brown, M.D. | Presidio Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Sacramento | California | 95817 | United States | ||
| Local institution |
Not provided
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | capsules, oral, once daily for 3 days |
|
| San Francisco |
| California |
| 94115 |
| United States |
| Local institution | Aarhus | Denmark |
| Local institution | Copenhagen | Denmark |
| Local institution | Herlev | Denmark |
| Local institution | Hvidovre | Denmark |
| Local institution | Kolding | Denmark |
| Local institution | Odense | Denmark |
| Local institution | London | NW3 2QG | United Kingdom |
| Local institution | London | SE5 9RS | United Kingdom |
| Local institution | London | W2 1NY | United Kingdom |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |