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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Recruitment Status : Withdrawn (Withdrawn prior to study initiation.)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.

Tracking Information
First Submitted Date  ICMJE March 13, 2020
First Posted Date  ICMJE March 16, 2020
Last Update Posted Date June 8, 2022
Estimated Study Start Date  ICMJE October 2021
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2020)
  • Incidence of Treatment-Emergent Adverse Events [ Time Frame: Through Day 6 for subjects in Part A ]
    Number of subjects experiencing treatment-emergent adverse events
  • 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
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2020)
  • AT-777 maximum plasma concentration (Cmax) [ Time Frame: Day 1 for subjects in Part A ]
    PK
  • AT-777 area under the concentration-time curve (AUC) [ Time Frame: Day 1 for subjects in Part A ]
    PK
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of AT-777 in Healthy Subjects and AT-777 in Combination With AT-527 in HCV-Infected Subjects
Official Title  ICMJE A Phase I/IIa Study Assessing AT-777 in Healthy Subjects and AT-777 in Combination With AT-527 in HCV-Infected Subjects
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • Hepatitis C
  • Hepatitis C, Chronic
  • Chronic Hepatitis C
  • Hepatitis C Virus Infection
  • HCV Infection
Intervention  ICMJE
  • 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: Placebo
    Administered orally, as one or two placebo capsules, 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.
Study Arms  ICMJE
  • Experimental: Part A - 60 mg AT-777 single dose
    Intervention: Drug: AT-777
  • Experimental: Part A - 120 mg AT-777 single dose
    Intervention: Drug: AT-777
  • Placebo Comparator: Part A - Placebo single dose
    Intervention: Drug: Placebo
  • Experimental: Part B - 60 mg AT-777 + 550 mg AT-527 once daily for 8 weeks
    Interventions:
    • Drug: AT-777
    • Drug: AT-527
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 6, 2022)
0
Original Estimated Enrollment  ICMJE
 (submitted: March 13, 2020)
26
Estimated Study Completion Date  ICMJE September 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04309734
Other Study ID Numbers  ICMJE AT-01C-001
2019-004997-24 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Atea Pharmaceuticals, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Atea Pharmaceuticals, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Xiao-Jian Zhou Atea Pharmaceuticals
PRS Account Atea Pharmaceuticals, Inc.
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP