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Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Dose escalation or repetition will be governed by pre-specified safety and activity rules. Subjects will be confined on either days 1-3 and/or days 8-10. Follow-up visits are also required periodically through day 43. Study procedures involve taking blood samples for pharmacokinetic, pharmacodynamic, virologic, and safety assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.3mg GS-9620 | Experimental |
| |
| 1mg GS-9620 | Experimental |
| |
| 2mg GS-9620 | Experimental |
| |
| 4mg GS-9620 | Experimental |
| |
| 0.3mg GS-9620 QW x 2 doses | Experimental |
| |
| 1mg GS-9620 QW x 2 doses | Experimental |
| |
| 2mg GS-9620 QW x 2 doses | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single Ascending Dose Cohorts GS-9620 | Drug | This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Subjects in Single Ascending Dose (SAD) Cohorts will receive a single dose of GS-9620. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events in single and multiple doses of GS-9620 | Assessments include adverse events, laboratory abnormalities, 12-lead ECG abnormalities and interval measurements, and vital sign measurements | Periodically Day 1 to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of plasma drug concentrations of GS-9620 using non-compartmental methods | Single ascending dose (SAD) cohorts: serial blood samples will be collected on Day 1 at 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 48, and 96 hours post-dose. Multiple ascending dose (MAD) cohorts: serial blood samples will be collected on Day 8 at 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hours post-dose. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Woodland International Research Group | Little Rock | Arkansas | 72211 | United States | ||
| Avail Clinical Research, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25105516 | Derived | Lawitz E, Gruener D, Marbury T, Hill J, Webster L, Hassman D, Nguyen AH, Pflanz S, Mogalian E, Gaggar A, Massetto B, Subramanian GM, McHutchison JG, Jacobson IM, Freilich B, Rodriguez-Torres M. Safety, pharmacokinetics and pharmacodynamics of the oral toll-like receptor 7 agonist GS-9620 in treatment-naive patients with chronic hepatitis C. Antivir Ther. 2015;20(7):699-708. doi: 10.3851/IMP2845. Epub 2014 Aug 8. |
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| 4mg GS-9620 QW x 2 doses | Experimental |
|
|
| Multiple Ascending Dose Cohorts GS-9620 | Drug | This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Subjects in Multiple Ascending Dose (MAD) Cohorts will receive GS-9620 once weekly for two weeks (QW x 2 doses). |
|
| Day 1 and Day 8 |
| Measurement of pharmacodynamic markers (cytokines and interferon-stimulated genes [ISGs]) | SAD cohorts: Whole blood and serum for pharmacodynamic (PD) assessments (RNA and cytokine analysis) will be drawn on Day 1: Pre-dose and 8-hour Post-dose, Day 2, Day 3, Day 5, Day 8 MAD cohorts: Whole blood and serum for PD assessments (RNA and cytokine analysis) will be drawn on Day 1: Pre-dose and 8-hours Post-dose, Day 2, Day 3, Day 5, Day 8: Pre-dose and 8 hours Post-dose, Day 9, Day 10, Day 12, and Day 15 | Days 1, 2, 3, 5, 8 |
| Reduction of hepatitis C (HCV) RNA viral load from baseline | SAD cohorts: HCV viral load will be drawn at Day 1: Pre-dose, Day 2, 3, 5, 8 and both Follow-up Visits. MAD cohorts: HCV viral load will be drawn at Day 1: Pre-dose, Day 2, 3, 5, Day 8: Pre-dose, 9, 10, 15, and both Follow-Up Visits. | Screening, Baseline, Day 8 or 15 |
| DeLand |
| Florida |
| 32720 |
| United States |
| Orlando Clinical Research Center | Orlando | Florida | 32809 | United States |
| Kansas City Gastroenterology and Hepatology | Kansas City | Missouri | 64131 | United States |
| Comprehensive Clinical Research | Berlin | New Jersey | 08009 | United States |
| CRI Worldwide, LLC | Willingboro | New Jersey | 08046 | United States |
| CliniLabs | New York | New York | 10019 | United States |
| CRI Worldwide, LLC | Philadelphia | Pennsylvania | 19139 | United States |
| Alamo Medical Research | San Antonio | Texas | 78215 | United States |
| Lifetree Clinical Research | Salt Lake City | Utah | 84106 | United States |
| Fundacion De Investigacion De Diego | Santurce | PR | 00909 | Puerto Rico |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D006505 | Hepatitis |
| 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 |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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