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This study has multiple parts. It will assess the safety, tolerability and pharmacokinetics (PK) of AT-527 in healthy subjects and subjects infected with hepatitis C virus (HCV). In addition, the study will assess the antiviral activity of AT-527 in subjects infected with HCV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AT-527 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AT-527 | Drug | Ascending doses of AT-527 administered orally. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Number of subjects experiencing treatment-emergent adverse events | Through Day 6 for subjects receiving a single dose |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Number of subjects experiencing treatment-emergent adverse events | Through Day 35 for subjects receiving multiple doses. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) of AT-527 | Maximum plasma concentration (Cmax) | Day 1 for subjects receiving a single dose; Days 1 and 7 for subjects receiving multiple doses |
| Pharmacokinetics (PK) of AT-527 |
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Inclusion Criteria:
All subjects (healthy and HCV-infected subjects):
Additional inclusion criteria for HCV-infected subjects:
Exclusion Criteria:
All subjects (healthy and HCV-infected subjects):
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| Name | Affiliation | Role |
|---|---|---|
| Xiao-Jian Zhou, PhD | Atea Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Antwerp | Belgium | ||||
| Clinical Trial Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31570394 | Result | Berliba E, Bogus M, Vanhoutte F, Berghmans PJ, Good SS, Moussa A, Pietropaolo K, Murphy RL, Zhou XJ, Sommadossi JP. Safety, pharmacokinetics and antiviral activity of AT-527, a novel purine nucleotide prodrug, in HCV-infected subjects with and without cirrhosis. Antimicrob Agents Chemother. 2019 Sep 9;63(12):e01201-19. doi: 10.1128/AAC.01201-19. Epub 2019 Sep 30. |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D006526 | Hepatitis C |
| D008107 | Liver Diseases |
| D006525 | Hepatitis, Viral, Human |
| D018178 | Flaviviridae Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| C000713067 | AT-511 |
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| Placebo Comparator |
| Other |
Matching placebo |
|
Area under the concentration-time curve (AUC)
| Day 1 for subjects receiving a single dose; Days 1 and 7 for subjects receiving multiple doses |
| Antiviral Activity of AT-527 | Change from baseline in plasma HCV RNA | Through Day 6 for subjects receiving a single dose; Through Day 35 for subjects receiving multiple doses. |
| Chisinau |
| Moldova |
| D012327 |
| RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |