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Study of AT-777 in Healthy Subjects and AT-777 in Combination With AT-527 in HCV-Infected Subjects

Primary Purpose

Hepatitis C, Hepatitis C, Chronic, Chronic Hepatitis C

Status

Withdrawn

Phase

Phase 1

Locations

Belgium

Study Type

Interventional

Intervention

AT-777

Placebo

AT-527

About this trial

This is an interventional treatment trial for Hepatitis C

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Clinical Trial Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Part A - 60 mg AT-777 single dose

Part A - 120 mg AT-777 single dose

Part A - Placebo single dose

Part B - 60 mg AT-777 + 550 mg AT-527 once daily for 8 weeks

Arm Description

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events

Number of subjects experiencing treatment-emergent adverse events

Incidence of Treatment-Emergent Adverse Events

Number of subjects experiencing treatment-emergent adverse events

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)

Secondary Outcome Measures

AT-777 maximum plasma concentration (Cmax)

AT-777 area under the concentration-time curve (AUC)

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

Full Information

NCT ID

NCT04309734

First Posted

March 13, 2020

Last Updated

June 6, 2022

Sponsor

Atea Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04309734

Brief Title

Study of AT-777 in Healthy Subjects and AT-777 in Combination With AT-527 in HCV-Infected Subjects

Official Title

A Phase I/IIa Study Assessing AT-777 in Healthy Subjects and AT-777 in Combination With AT-527 in HCV-Infected Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Withdrawn

Why Stopped

Withdrawn prior to study initiation.

Study Start Date

October 2021 (Anticipated)

Primary Completion Date

June 2022 (Anticipated)

Study Completion Date

September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Atea Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C, Hepatitis C, Chronic, Chronic Hepatitis C, Hepatitis C Virus Infection, HCV Infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Sequential Assignment

Masking

ParticipantCare ProviderInvestigator

Masking Description

Part A is randomized, double-blind. Part B is open label.

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part A - 60 mg AT-777 single dose

Arm Type

Experimental

Arm Title

Part A - 120 mg AT-777 single dose

Arm Type

Experimental

Arm Title

Part A - Placebo single dose

Arm Type

Placebo Comparator

Arm Title

Part B - 60 mg AT-777 + 550 mg AT-527 once daily for 8 weeks

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

AT-777

Intervention Description

Administered orally as one or two 60 mg capsule(s) of AT-777 (inhibitor of HCV nonstructural protein 5A (NS5A)), depending on the arm.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered orally, as one or two placebo capsules, depending on the arm.

Intervention Type

Drug

Intervention Name(s)

AT-527

Intervention Description

Administered orally as one 550 mg tablet of AT-527 (nucleotide prodrug inhibitor of HCV nonstructural protein 5B (NS5B) polymerase), depending on the arm.

Primary Outcome Measure Information:

Title

Incidence of Treatment-Emergent Adverse Events

Description

Number of subjects experiencing treatment-emergent adverse events

Time Frame

Through Day 6 for subjects in Part A

Title

Incidence of Treatment-Emergent Adverse Events

Description

Number of subjects experiencing treatment-emergent adverse events

Time Frame

Through 4 weeks after end of treatment for subjects in Part B

Title

Antiviral Activity of AT-777 and AT-527

Description

Number of subjects who achieve plasma HCV RNA < lower limit of quantitation (LLOQ) and target not detected (TND)

Time Frame

Through 2 weeks of treatment for subjects in Part B

Secondary Outcome Measure Information:

Title

AT-777 maximum plasma concentration (Cmax)

Description

Time Frame

Day 1 for subjects in Part A

Title

AT-777 area under the concentration-time curve (AUC)

Description

Time Frame

Day 1 for subjects in Part A

Title

Proportion of subjects achieving sustained virologic response (SVR)

Description

SVR defined as the HCV RNA < lower limit of quantitation (LLOQ) at 12 weeks after end of treatment

Time Frame

12 weeks after end of treatment for subjects in Part B

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiao-Jian Zhou

Organizational Affiliation

Atea Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Clinical Trial Site

City

Antwerp

Country

Belgium

12. IPD Sharing Statement

Learn more about this trial

Study of AT-777 in Healthy Subjects and AT-777 in Combination With AT-527 in HCV-Infected Subjects

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