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

Healthy Volunteer Study Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05256732
• Other study ID #: AT-03A-015
• Status: Completed
• Phase: Phase 1
• Start date: February 22, 2022
• Est. completion date: August 23, 2022

Study information

• Verified date: October 2022
• Source: Atea Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: August 23, 2022
• Est. primary completion date: August 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteer Study

Intervention

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

Other:
• Placebo Comparator fasted
Matching placebo administered twice daily (BID) for 5 days fasted

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

Other:
• Placebo Comparator fed
Matching placebo administered twice daily (BID) for 5 days fed

Drug:
• AT-527
AT-527 administered twice daily (BID)
• AT-527 single dose
AT-527 single dose fasted/fed cross-over

Locations

Country	Name	City	State
Canada	Atea Study Site	Québec	Montreal, Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Atea Pharmaceuticals, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK) of AT-527	Maximum plasma concentration (Cmax)	Day 1
Primary	Pharmacokinetics (PK) of AT-527	Area under the concentration-time curve (AUC)	Day 1
Primary	Pharmacokinetics (PK) of AT-527	Trough plasma concentration (Ctrough)	Day 1
Primary	Proportions of subjects experiencing treatment-emergent adverse events		Day 1-10