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Clinical trial

A Phase 1, Open-Label Study to Evaluate the Potential Drug-Drug Interaction Between Bemnifosbuvir and Ruzasvir and Food-Drug Interaction in Healthy Adult Subjects

ID
Name
AT-01B-003
Description
Drug-drug interaction study of Ruzasvir and Bemnifosbuvir
Trial arms
Trial start
2023-01-30
Estimated PCD
2023-03-15
Trial end
2023-03-15
Status
Completed
Phase
Early phase I
Treatment
Cohort 1 BEM + Ruzasvir
Days 1 to 6 BEM under fasting conditions. Days 7 to 12 of BEM and Ruzasvir coadministered under fasting conditions. Days 13 to 18 of BEM and Ruzasvir coadministered under fed conditions
Arms:
BEM vs BEM + Ruzasvir n=16
Other names:
AT-527
Cohort 2 Ruzasvir + BEM
Days 1 to 6 of Ruzasvir under fasting conditions. Days 7 to 12 of Ruzasvir and BEM coadministered under fasting conditions. Days 13 to 18 of Ruzasvir and BEM coadministered under fed conditions
Arms:
Ruzasvir vs Ruzasvir + BEM n=16
Other names:
AT-527
Size
32
Primary endpoint
Pharmacokinetics (PK) of BEM
Days 6, 12, 18
Pharmacokinetics (PK) of Ruzasvir
Days 6, 12, 18
Eligibility criteria
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. * 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 32, 'type': 'ACTUAL'}}
Updated at
2023-06-01

1 organization

2 products

1 indication

Organization
Atea Pharmaceuticals
Product
Cohort 1 BEM + Ruzasvir
Indication
Healthy Volunteer Study
Product
Ruzasvir + BEM