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Clinical Trials/NCT04865445
NCT04865445CompletedPhase 1

A Phase 1 Open-Label Study to Evaluate the Interaction Potential Between AT 527 and Midazolam in Healthy Adult Subjects

Atea Pharmaceuticals, Inc.1 site in 1 country24 target enrollmentStarted: April 22, 2021Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
24
Locations
1
Primary Endpoint
Pharmacokinetics (PK) of midazolam
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Drug-drug interaction study of midazolam and AT-527 (R07496998)

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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 18-29 kg/m2
  • •Willing to comply with the study requirements and to provide written informed consent

Exclusion Criteria

  • •Infected with hepatitis B virus, hepatitis C virus, HIV or SARS-CoV-2
  • •Abuse of alcohol or drugs
  • •Use of other investigational drugs within 28 days of dosing
  • •Concomitant use of prescription medications, or systemic over-the-counter medications
  • •Other clinically significant medical conditions or laboratory abnormalities

Arms & Interventions

AT-527 550 mg + midazolam (simultaneous)

Experimental

n=12

Intervention: AT-527 550 mg + midazolam (Drug)

AT-527 mg + midazolam (staggered)

Experimental

n=12

Intervention: AT-527 550 mg + midazolam (Drug)

Outcomes

Primary Outcomes

Pharmacokinetics (PK) of midazolam

Time Frame: Day 1, Day 3, Day 7

Maximum plasma concentration (Cmax) and Area under the concentration-time curve (AUC)

Secondary Outcomes

  • Pharmacokinetics (PK) of AT-527(Day 3, Day 7)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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