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Completed

NCT Number: NCT03219957

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

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.

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Key information

Conditions

Chronic Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Trial Site, Antwerp, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AT-527

Drug

Ascending doses of AT-527 administered orally.

Placebo Comparator

Other

Matching placebo

Primary outcomes

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

    Time frame: Through Day 6 for subjects receiving a single dose

    Number of subjects experiencing treatment-emergent adverse events

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

    Time frame: Through Day 35 for subjects receiving multiple doses.

    Number of subjects experiencing treatment-emergent adverse events

Secondary outcomes

  1. Pharmacokinetics (PK) of AT-527

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

    Maximum plasma concentration (Cmax)

  2. Pharmacokinetics (PK) of AT-527

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

    Area under the concentration-time curve (AUC)

  3. Antiviral Activity of AT-527

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

    Change from baseline in plasma HCV RNA

Sponsors and collaborators

Lead sponsor

Atea Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Phase I Study Assessing Single and Multiple Doses of AT-527 in Healthy and HCV-Infected Subjects

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 18, 2017
Registry last updated
Feb 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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