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The overall study design includes two parts, Part A and Part B.
Part A evaluated ANA773 following oral administration to healthy volunteers. A total of 40 evaluable healthy volunteers were enrolled in Part A of the study.
Part B evaluated ANA773 following oral administration to patients with chronic HCV infection. A total of 34 evaluable patients were enrolled in Part B of this study in 2 study centers.
Study Design:
Part A evaluated ANA773 following oral administration to healthy volunteers. A total of 40 evaluable healthy volunteers were enrolled in Part A of the study.
Part B evaluated ANA773 following oral administration to patients with chronic HCV infection. A total of 34 evaluable patients were enrolled in Part B of this study in 2 study centers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A, Group 1 Healthy Volunteer | Active Comparator | a single oral dose (Period 1) and multiple oral doses every other day (4 administrations) (Period 2) of 200 mg of ANA773 (n=6) or placebo (n=2) |
|
| Part A, Group 2 Healthy Volunteer | Active Comparator | a single oral dose (Period 1) and multiple oral doses every other day (4 administrations) (Period 2) of 400 mg of ANA773 (n=6) or placebo (n=2) |
|
| Part A, Group 3 Healthy Volunteer | Active Comparator | a single oral dose (Period 1) and multiple oral doses every other day (4 administrations) (Period 2) of 800 mg of ANA773 (n=6) or placebo (n=2) |
|
| Part A, Group 4 Healthy Volunteer | Active Comparator | a single oral dose (Period 1) and multiple oral doses every other day (4 administrations) (Period 2) of 1200 mg of ANA773 (n=6) or placebo (n=2) |
|
| Part A, Group 5 Healthy Volunteer | Active Comparator | a single oral dose (Period 1) and multiple oral doses every other day (4 administrations) (Period 2) of 1600 mg of ANA773 (n=6) or placebo (n=2) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ANA773 | Drug | ANA773 Tosylate Capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Pharmacokinetic Analysis in both Healthy Subjects and Chronic HCV Patients | Evaluate the Safety and Pharmacokinetic Analysis in both Healthy Subjects and Chronic HCV Patients | Up to 41 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Immunological effects in both Healthy Subjects and Chronic HCV Patients | Evaluate the immunological effects and antiviral activity as assessed by changes in HCV RNA levels. | Up to 41 days |
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Part A Inclusion:
Part A Exclusion:
Part B Inclusion Criteria:
Part B Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academisch Medisch Centrum (AMC) | Amsterdam | Netherlands | ||||
| PRA Clinical Research Unit |
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|
| Part B, Group 6 HCV Infected Patient | Active Comparator | multiple oral doses(14 administrations) every other day of 2000 mg of ANA773 (n=6) or placebo (n=2) |
|
| Part B, Group 7 HCV Infected Patient | Active Comparator | multiple oral doses(14 administrations) every other day of 1200 mg of ANA773 (n=6) or placebo (n=2) |
|
| Part B, Group 8 HCV Infected Patient | Active Comparator | multiple oral doses(14 administrations) every other day of 1600 mg of ANA773 (n=6) or placebo (n=2) |
|
| Part B, Group 9 HCV Infected Patient | Active Comparator | multiple oral doses(5 administrations) every other day of 2000 mg of ANA773 (n=8) or placebo (n=2) |
|
| Placebo | Drug | Matching Placebo Capsule |
|
| Groningen |
| Netherlands |
| Erasmus MC (EMC) | Rotterdam | Netherlands |
| ID | Term |
|---|---|
| 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 |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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