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PPI-668 is an antiviral agent (a hepatitis C NS5A inhibitor) that is being developed as a potential treatment for hepatitis C virus infection. This study is being done to assess the safety and tolerance of PPI-668 when given to healthy volunteers for up to 5 days (Part I of the study) and to hepatitis C patients for up to 3 days (Part II). In addition, the study will assess how much PPI-668 is absorbed into the bloodstream. In Part II, the effect of PPI-668 on the amount of hepatitis C virus in patients' bloodstream (serum HCV RNA levels) also will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part I: single dose escalation in healthy volunteers | Experimental | There will be three sequential single dose cohorts: Cohort A: PPI-668 dose D1 or placebo Cohort B: PPI-668 dose D2 or placebo Cohort C: PPI-668 dose D3 or placebo |
|
| Part I: multiple dose administration to healthy volunteers | Experimental | Upon completion of the single dose escalation phase, an additional cohort will receive repeat doses: Cohort D: highest well-tolerated dose from Cohorts A-C or placebo once daily for five days |
|
| Part II: multiple dose escalation in HCV subjects | Experimental | Upon completion of Part I, there will be 3, and potentially 4, sequential cohorts of HCV patients: Cohort E (genotype-1): PPI-668 dose E1 or placebo Cohort F (genotype-1): PPI-668 dose E2 or placebo Cohort G (genotype-1): PPI-668 dose E3 or placebo Cohort H (genotype-1): if necessary for dose-response assessment; dose to be determined Cohort I (genotype-2 or -3): PPI-668 dose E4 or placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PPI-668 | Drug | capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability, as measured by clinical adverse events and laboratory assessments | Part I, up to day 12; and Part II, up to day 17 |
| Measure | Description | Time Frame |
|---|---|---|
| PPI-668 plasma levels | Part I, up to day 12; and Part II, up to day 17 | |
| serum HCV RNA levels | Part II, up to day 17 |
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In order to participate in the study, volunteers for Part I and patients for Part II must meet all of the following key entry criteria, as well as other entry criteria specified in the full protocol:
Key Inclusion Criteria
Key Exclusion Criteria:
Additional Key Entry Criteria for HCV patients (Part II):
Clinical diagnosis of chronic hepatitis C, documented by:
ALT must be <5 x ULN at screen
No previous treatment with interferon, pegIFN, or ribavirin for genotype-1 patients
No history of signs or symptoms of decompensated liver disease
Any of the following laboratory values at Screening will be exclusionary for study participation:
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| Name | Affiliation | Role |
|---|---|---|
| Nathaniel Brown, M.D. | Presidio Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational site | Costa Mesa | California | United States | |||
| Investigational site |
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| Placebo | Drug | capsules |
|
| Sacramento |
| California |
| United States |
| Investigational site | San Francisco | California | United States |
| Investigational Site | San Antonio | Texas | United States |
| Investigational site | Canberra | Australia |
| Investigational site | Auckland | New Zealand |
| Investigational site | Christchurch | New Zealand |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000621711 | ravidasvir |
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