NCT03219957

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2017

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 6, 2017

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 18, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2018

Completed
Last Updated

February 18, 2020

Status Verified

February 1, 2020

Enrollment Period

12 months

First QC Date

July 13, 2017

Last Update Submit

February 14, 2020

Conditions

Chronic Hepatitis CHepatitis CHepatitis C, Chronic

Keywords

HCVHepatitis C VirusRNA VirusesFlavivirusLiver DiseasesHepatitis, Viral, HumanFlaviviridae Infections

Outcome Measures

Primary Outcomes (2)

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Number of subjects experiencing treatment-emergent adverse events

    Through Day 6 for subjects receiving a single dose

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Number of subjects experiencing treatment-emergent adverse events

    Through Day 35 for subjects receiving multiple doses.

Secondary Outcomes (3)

  • Pharmacokinetics (PK) of AT-527

    Day 1 for subjects receiving a single dose; Days 1 and 7 for subjects receiving multiple doses

  • Pharmacokinetics (PK) of AT-527

    Day 1 for subjects receiving a single dose; Days 1 and 7 for subjects receiving multiple doses

  • Antiviral Activity of AT-527

    Through Day 6 for subjects receiving a single dose; Through Day 35 for subjects receiving multiple doses.

Study Arms (2)

AT-527

EXPERIMENTAL
Drug: AT-527

Placebo

PLACEBO COMPARATOR
Other: Placebo Comparator

Interventions

AT-527DRUG

Ascending doses of AT-527 administered orally.

AT-527
Placebo ComparatorOTHER

Matching placebo

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinical Trial Site

Antwerp, Belgium

Location

Clinical Trial Site

Chisinau, Moldova

Location

Related Publications (1)

  • 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.

    PMID: 31570394RESULT

MeSH Terms

Conditions

Hepatitis C, ChronicHepatitis CLiver DiseasesHepatitis, Viral, HumanFlaviviridae Infections

Interventions

AT-511

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsVirus DiseasesRNA Virus InfectionsHepatitis, ChronicHepatitisDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Xiao-Jian Zhou, PhD

    Atea Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2017

First Posted

July 18, 2017

Study Start

July 6, 2017

Primary Completion

June 20, 2018

Study Completion

June 20, 2018

Last Updated

February 18, 2020

Record last verified: 2020-02

Locations

MO(1)BE(1)