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This study will examine the effectiveness of 15 days of therapy with SCY-635 in reducing hepatitis C virus (HCV) RNA levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo comparator | Placebo Comparator |
| |
| SCY-635 30 mg once daily | Active Comparator |
| |
| SCY-635 100 mg once daily | Active Comparator |
| |
| SCY-635 300 mg once daily | Active Comparator |
| |
| SCY-635 100 mg three times daily | Active Comparator |
| |
| SCY-635 200 mg three times daily | Active Comparator |
| |
| SCY-635 300 mg three times daily | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Oral tablet given once or three times daily for 15 consecutive days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma HCV RNA level | 22 days | |
| Incidence and severity of treatment-emergent adverse events and changes in laboratory values as measures of safety and tolerability. | 22 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic assessment of SCY-635 | 22 days |
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Inclusion Criteria:
A potential subject will be eligible for participation in this study if he or she meets all of the following inclusion criteria:
Exclusion Criteria:
A potential subject will be excluded from participation in the study if he or she meets any of the following exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas Heuman, MD | McGuire Veterans Affairs Medical Center, Richmond, Virginia | Principal Investigator |
| Jacob Lalezari, MD | Quest Clinical Research, San Francisco, California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quest Clinical Research | San Francisco | California | 94115 | United States | ||
| McGuire Veterans Affairs Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22425702 | Derived | Hopkins S, DiMassimo B, Rusnak P, Heuman D, Lalezari J, Sluder A, Scorneaux B, Mosier S, Kowalczyk P, Ribeill Y, Baugh J, Gallay P. The cyclophilin inhibitor SCY-635 suppresses viral replication and induces endogenous interferons in patients with chronic HCV genotype 1 infection. J Hepatol. 2012 Jul;57(1):47-54. doi: 10.1016/j.jhep.2012.02.024. Epub 2012 Mar 13. |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C544142 | SCY-635 |
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| SCY-635 |
| Drug |
oral capsule |
|
| Richmond |
| Virginia |
| 23249 |
| United States |
| 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 |