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

NCT05256732
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Phase
Phase 1
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Recruitment status
Completed
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Participants
136
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Lead sponsor
Atea Pharmaceuticals, Inc.
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Start date
2022-02-22
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Number of sites
1
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Summary
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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Short title
Study of AT-527 in Healthy Subjects Under Fasting Conditions or With a Meal
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Official 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
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 1
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Study type
Interventional
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Completion date
2022-08-23
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First posted
2022-02-25
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Registry last updated
2022-10-18
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Primary completion date
2022-08-23
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Start date
2022-02-22
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Actual participants
136
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Participants
136
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Participant count basis
Actual
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Protocol amendments
1
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Number of sites
1
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Atea Pharmaceuticals, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05256732
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ClinicalTrials.gov ID
NCT05256732
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Triple masking
Masked roles
Participants, Care providers, Investigators
Sources for study design
clinicaltrials.gov

  1. Pharmacokinetics (PK) of AT-527

    Timeframe: Day 1

    Maximum plasma concentration (Cmax)

  2. Pharmacokinetics (PK) of AT-527

    Timeframe: Day 1

    Area under the concentration-time curve (AUC)

  3. Pharmacokinetics (PK) of AT-527

    Timeframe: Day 1

    Trough plasma concentration (Ctrough)

  4. Proportions of subjects experiencing treatment-emergent adverse events

    Timeframe: Day 1-10

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
Yes

  • 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

  • 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
Sources for eligibility
clinicaltrials.gov

  • Atea Study SiteQuébec, Canada
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)