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Completed

NCT Number: NCT05256732

Study of AT-527 in Healthy Subjects Under Fasting Conditions or With a Meal

This study will assess the safety, tolerability and pharmacokinetics (PK) of AT-527 following oral administration under fasting conditions or with a meal in healthy adult subjects

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Key information

Conditions

Healthy Volunteer Study

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Atea Study Site

Québec, Montreal, Quebec, Canada

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug
  • Females must have a negative pregnancy test at Screening and prior to dosing
  • Minimum body weight of 50 kg and body mass index (BMI) of 18-32 kg/m2
  • Willing to comply with the study requirements and to provide written informed consent

Exclusion criteria

  • Pregnant or breastfeeding
  • Infected with hepatitis B virus, hepatitis C virus, HIV or COVID-19
  • 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 fasted

Drug

AT-527 administered twice daily (BID) for 5 days fasted

Other names: Bemnifosbuvir

Placebo Comparator fasted

Other

Matching placebo administered twice daily (BID) for 5 days fasted

AT-527 fed

Drug

AT-527 administered twice daily (BID) for 5 days fed

Other names: Bemnifosbuvir

Placebo Comparator fed

Other

Matching placebo administered twice daily (BID) for 5 days fed

AT-527

Drug

AT-527 administered twice daily (BID)

Other names: Bemnifosbuvir

AT-527 single dose

Drug

AT-527 single dose fasted/fed cross-over

Other names: Bemnifosbuvir

Primary outcomes

  1. Pharmacokinetics (PK) of AT-527

    Time frame: Day 1

    Maximum plasma concentration (Cmax)

  2. Pharmacokinetics (PK) of AT-527

    Time frame: Day 1

    Area under the concentration-time curve (AUC)

  3. Pharmacokinetics (PK) of AT-527

    Time frame: Day 1

    Trough plasma concentration (Ctrough)

  4. Proportions of subjects experiencing treatment-emergent adverse events

    Time frame: Day 1-10

Sponsors and collaborators

Lead sponsor

Atea Pharmaceuticals, Inc.

Industry

Registry information

Official study title

Phase 1, Multiple Dose, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AT-527 Following Oral Administration Under Fasting Conditions or With a Meal in Healthy Adult Subjects

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 25, 2022
Registry last updated
Oct 18, 2022

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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