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

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ClinicalTrials.gov Identifier: NCT04309734
Recruitment Status : Withdrawn (Withdrawn prior to study initiation.)
First Posted : March 16, 2020
Last Update Posted : June 8, 2022
Sponsor:
Information provided by (Responsible Party):
Atea Pharmaceuticals, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hepatitis C Hepatitis C, Chronic Chronic Hepatitis C Hepatitis C Virus Infection HCV Infection Drug: AT-777 Drug: Placebo Drug: AT-527 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Part A is randomized, double-blind. Part B is open label.
Primary Purpose: Treatment
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
Estimated Study Start Date : October 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Part A - 60 mg AT-777 single dose 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.
Experimental: Part A - 120 mg AT-777 single dose 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 Comparator: Part A - Placebo single dose Drug: Placebo
Administered orally, as one or two placebo capsules, depending on the arm.
Experimental: Part B - 60 mg AT-777 + 550 mg AT-527 once daily for 8 weeks 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.

Drug: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: Through Day 6 for subjects in Part A ]
    Number of subjects experiencing treatment-emergent adverse events

  2. Incidence of Treatment-Emergent Adverse Events [ Time Frame: Through 4 weeks after end of treatment for subjects in Part B ]
    Number of subjects experiencing treatment-emergent adverse events

  3. Antiviral Activity of AT-777 and AT-527 [ Time Frame: 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 Outcome Measures :
  1. AT-777 maximum plasma concentration (Cmax) [ Time Frame: Day 1 for subjects in Part A ]
    PK

  2. AT-777 area under the concentration-time curve (AUC) [ Time Frame: Day 1 for subjects in Part A ]
    PK

  3. Proportion of subjects achieving sustained virologic response (SVR) [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04309734


Locations
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Belgium
Clinical Trial Site
Antwerp, Belgium
Sponsors and Collaborators
Atea Pharmaceuticals, Inc.
Investigators
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Study Director: Xiao-Jian Zhou Atea Pharmaceuticals
More Information
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Responsible Party: Atea Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04309734    
Other Study ID Numbers: AT-01C-001
2019-004997-24 ( EudraCT Number )
First Posted: March 16, 2020    Key Record Dates
Last Update Posted: June 8, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Disease Attributes
Pathologic Processes
Liver Diseases
 Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Flaviviridae Infections
Hepatitis, Chronic