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

Phase 1

Completed

• Conditions: Healthy Volunteer Study
• Interventions: Drug: AT-527; Drug: AT-527 fasted; Other: Placebo Comparator fasted; Drug: AT-527 single dose; Other: Placebo Comparator fed; Drug: AT-527 fed

• Registration Number: NCT05256732
• Lead Sponsor: Atea Pharmaceuticals, Inc.

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-16
• Study First Submitted QC: 2022-02-16
• Study Start: 2022-02-22
• Study First Posted: 2022-02-25
• Primary Completion: 2022-08-23
• Study Completion: 2022-08-23
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-14
• Last Update Posted: 2022-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AT-527 BID	AT-527	-
AT-527	AT-527 fasted	-
Placebo	Placebo Comparator fasted	-
Placebo	Placebo Comparator fed	-
AT-527 single dose fasted/fed	AT-527 single dose	-
AT-527	AT-527 fed	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK) of AT-527	Day 1	Trough plasma concentration (Ctrough)
Proportions of subjects experiencing treatment-emergent adverse events	Day 1-10

Trial Locations

Locations (1)

Atea Study Site; 🇨🇦 Québec, Montreal, Quebec, Canada