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Study of AT-527 in Healthy and HCV-Infected Subjects

Primary Purpose

Chronic Hepatitis C, Hepatitis C, Hepatitis C, Chronic

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
AT-527
Placebo Comparator
Sponsored by
Atea Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring HCV, Hepatitis C Virus, RNA Viruses, Flavivirus, Liver Diseases, Hepatitis, Viral, Human, Flaviviridae Infections

Eligibility Criteria

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

Inclusion Criteria:

All subjects (healthy and HCV-infected subjects):

  • Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug
  • Must have a negative pregnancy test at Screening and prior to dosing
  • Minimum body weight of 50 kg
  • Willing to comply with the study requirements and to provide written informed consent

Additional inclusion criteria for HCV-infected subjects:

  • Must have not received prior treatment for HCV infection
  • Documented clinical history compatible with chronic HCV infection
  • Plasma HCV RNA ≥ 5.0 log10 IU/mL at Screening.

Exclusion Criteria:

All subjects (healthy and HCV-infected subjects):

  • Pregnant or breastfeeding
  • Infected with hepatitis B virus or HIV
  • Abuse of alcohol or drugs
  • Use of other investigational drugs within 28 days of dosing
  • Other clinically significant medical conditions or laboratory abnormalities

Sites / Locations

  • Clinical Trial Site
  • Clinical Trial Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AT-527

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Number of subjects experiencing treatment-emergent adverse events
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Number of subjects experiencing treatment-emergent adverse events

Secondary Outcome Measures

Pharmacokinetics (PK) of AT-527
Maximum plasma concentration (Cmax)
Pharmacokinetics (PK) of AT-527
Area under the concentration-time curve (AUC)
Antiviral Activity of AT-527
Change from baseline in plasma HCV RNA

Full Information

First Posted
July 13, 2017
Last Updated
February 14, 2020
Sponsor
Atea Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03219957
Brief Title
Study of AT-527 in Healthy and HCV-Infected Subjects
Official Title
A Phase I Study Assessing Single and Multiple Doses of AT-527 in Healthy and HCV-Infected Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
July 6, 2017 (Actual)
Primary Completion Date
June 20, 2018 (Actual)
Study Completion Date
June 20, 2018 (Actual)

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
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study has multiple parts. It will assess the safety, tolerability and pharmacokinetics (PK) of AT-527 in healthy subjects and subjects infected with hepatitis C virus (HCV). In addition, the study will assess the antiviral activity of AT-527 in subjects infected with HCV.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C, Hepatitis C, Hepatitis C, Chronic
Keywords
HCV, Hepatitis C Virus, RNA Viruses, Flavivirus, Liver Diseases, Hepatitis, Viral, Human, Flaviviridae Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AT-527
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AT-527
Intervention Description
Ascending doses of AT-527 administered orally.
Intervention Type
Other
Intervention Name(s)
Placebo Comparator
Intervention Description
Matching placebo
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
Number of subjects experiencing treatment-emergent adverse events
Time Frame
Through Day 6 for subjects receiving a single dose
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
Number of subjects experiencing treatment-emergent adverse events
Time Frame
Through Day 35 for subjects receiving multiple doses.
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK) of AT-527
Description
Maximum plasma concentration (Cmax)
Time Frame
Day 1 for subjects receiving a single dose; Days 1 and 7 for subjects receiving multiple doses
Title
Pharmacokinetics (PK) of AT-527
Description
Area under the concentration-time curve (AUC)
Time Frame
Day 1 for subjects receiving a single dose; Days 1 and 7 for subjects receiving multiple doses
Title
Antiviral Activity of AT-527
Description
Change from baseline in plasma HCV RNA
Time Frame
Through Day 6 for subjects receiving a single dose; Through Day 35 for subjects receiving multiple doses.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All subjects (healthy and HCV-infected subjects): Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug Must have a negative pregnancy test at Screening and prior to dosing Minimum body weight of 50 kg Willing to comply with the study requirements and to provide written informed consent Additional inclusion criteria for HCV-infected subjects: Must have not received prior treatment for HCV infection Documented clinical history compatible with chronic HCV infection Plasma HCV RNA ≥ 5.0 log10 IU/mL at Screening. Exclusion Criteria: All subjects (healthy and HCV-infected subjects): Pregnant or breastfeeding Infected with hepatitis B virus or HIV Abuse of alcohol or drugs Use of other investigational drugs within 28 days of dosing Other clinically significant medical conditions or laboratory abnormalities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiao-Jian Zhou, PhD
Organizational Affiliation
Atea Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Trial Site
City
Antwerp
Country
Belgium
Facility Name
Clinical Trial Site
City
Chisinau
Country
Moldova, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
31570394
Citation
Berliba E, Bogus M, Vanhoutte F, Berghmans PJ, Good SS, Moussa A, Pietropaolo K, Murphy RL, Zhou XJ, Sommadossi JP. Safety, pharmacokinetics and antiviral activity of AT-527, a novel purine nucleotide prodrug, in HCV-infected subjects with and without cirrhosis. Antimicrob Agents Chemother. 2019 Sep 9;63(12):e01201-19. doi: 10.1128/AAC.01201-19. Epub 2019 Sep 30.
Results Reference
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Study of AT-527 in Healthy and HCV-Infected Subjects

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