Hepatitis C Clinical Trial
Official title:
A Phase I Study Assessing Single and Multiple Doses of AT-527 in Healthy and HCV-Infected Subjects
Verified date | February 2020 |
Source | Atea Pharmaceuticals, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 88 |
Est. completion date | June 20, 2018 |
Est. primary completion date | June 20, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: All subjects (healthy and HCV-infected subjects): - Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug - Must have a negative pregnancy test at Screening and prior to dosing - Minimum body weight of 50 kg - Willing to comply with the study requirements and to provide written informed consent Additional inclusion criteria for HCV-infected subjects: - Must have not received prior treatment for HCV infection - Documented clinical history compatible with chronic HCV infection - Plasma HCV RNA = 5.0 log10 IU/mL at Screening. Exclusion Criteria: All subjects (healthy and HCV-infected subjects): - Pregnant or breastfeeding - Infected with hepatitis B virus or HIV - Abuse of alcohol or drugs - Use of other investigational drugs within 28 days of dosing - Other clinically significant medical conditions or laboratory abnormalities |
Country | Name | City | State |
---|---|---|---|
Belgium | Clinical Trial Site | Antwerp | |
Moldova, Republic of | Clinical Trial Site | Chisinau |
Lead Sponsor | Collaborator |
---|---|
Atea Pharmaceuticals, Inc. |
Belgium, Moldova, Republic of,
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 cir — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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. | |
Secondary | 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 | |
Secondary | Pharmacokinetics (PK) of AT-527 | Area under the concentration-time curve (AUC) | Day 1 for subjects receiving a single dose; Days 1 and 7 for subjects receiving multiple doses | |
Secondary | 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. |
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