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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04309734
Other study ID # AT-01C-001
Secondary ID 2019-004997-24
Status Withdrawn
Phase Phase 1/Phase 2
First received
Last updated
Start date October 2021
Est. completion date September 2022

Study information

Verified date June 2022
Source Atea Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date September 2022
Est. primary completion date June 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Intervention

Drug:
AT-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.
Placebo
Administered orally, as one or two placebo capsules, depending on the arm.
AT-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.

Locations

Country Name City State
Belgium Clinical Trial Site Antwerp

Sponsors (1)

Lead Sponsor Collaborator
Atea Pharmaceuticals, Inc.

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Treatment-Emergent Adverse Events Number of subjects experiencing treatment-emergent adverse events Through Day 6 for subjects in Part A
Primary Incidence of Treatment-Emergent Adverse Events Number of subjects experiencing treatment-emergent adverse events Through 4 weeks after end of treatment for subjects in Part B
Primary Antiviral Activity of AT-777 and AT-527 Number of subjects who achieve plasma HCV RNA < lower limit of quantitation (LLOQ) and target not detected (TND) Through 2 weeks of treatment for subjects in Part B
Secondary AT-777 maximum plasma concentration (Cmax) PK Day 1 for subjects in Part A
Secondary AT-777 area under the concentration-time curve (AUC) PK Day 1 for subjects in Part A
Secondary Proportion of subjects achieving sustained virologic response (SVR) SVR defined as the HCV RNA < lower limit of quantitation (LLOQ) at 12 weeks after end of treatment 12 weeks after end of treatment for subjects in Part B
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