Chronic Hepatitis C, HCV Infection, Hepatitis C, Hepatitis C, Chronic, Hepatitis C Virus Infection
Conditions
Brief summary
This study has two parts. Part A will assess the safety, tolerability and pharmacokinetics (PK) of AT-777 in healthy subjects. Part B will assess the safety, antiviral activity/efficacy and PK of AT-777 in combination with AT-527 after 8 weeks of treatment in HCV-infected subjects.
Interventions
DRUGAT-777
Administered orally as one or two 60 mg capsule(s) of AT-777 (inhibitor of HCV nonstructural protein 5A (NS5A)), depending on the arm.
DRUGPlacebo
Administered orally, as one or two placebo capsules, depending on the arm.
DRUGAT-527
Administered orally as one 550 mg tablet of AT-527 (nucleotide prodrug inhibitor of HCV nonstructural protein 5B (NS5B) polymerase), depending on the arm.
Sponsors
Atea Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Part A is randomized, double-blind. Part B is open label.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
All: * Body mass index (BMI) of 18-35 kg/m2 * Must agree to use protocol-specified methods of contraception * Negative pregnancy test * Willing to comply with the study requirements and to provide written informed consent Additional for Part A: -18-55 years of age Additional for Part B: * 18-65 years of age * HCV genotype 1, 2 or 3 * Documented history compatible with chronic hepatitis C * HCV RNA ≥ 10,000 IU/mL at Screening
Exclusion criteria
All: * Pregnant or breastfeeding * Abuse of alcohol or drugs * Use of other investigational drugs within 30 days of dosing * Other clinically significant medical conditions Additional for Part B: * Prior exposure to any HCV NS5A inhibitor * Cirrhosis * Co-infection with hepatitis B virus or HIV
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Through Day 6 for subjects in Part A | Number of subjects experiencing treatment-emergent adverse events |
| Antiviral Activity of AT-777 and AT-527 | Through 2 weeks of treatment for subjects in Part B | Number of subjects who achieve plasma HCV RNA \< lower limit of quantitation (LLOQ) and target not detected (TND) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AT-777 maximum plasma concentration (Cmax) | Day 1 for subjects in Part A | PK |
| AT-777 area under the concentration-time curve (AUC) | Day 1 for subjects in Part A | PK |
| Proportion of subjects achieving sustained virologic response (SVR) | 12 weeks after end of treatment for subjects in Part B | SVR defined as the HCV RNA \< lower limit of quantitation (LLOQ) at 12 weeks after end of treatment |
Countries
Belgium
Outcome results
None listed