Drug-drug Interaction Study of Ruzasvir and Bemnifosbuvir
NCT ID: NCT05731843
Last Updated: 2023-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
32 participants
INTERVENTIONAL
2023-01-30
2023-03-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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BEM vs BEM + Ruzasvir n=16
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
Ruzasvir vs Ruzasvir + BEM n=16
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
Interventions
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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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
55 Years
ALL
Yes
Sponsors
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Atea Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Atea Study Site
Québec, Montreal, Quebec, Canada
Countries
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Other Identifiers
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AT-01B-003
Identifier Type: -
Identifier Source: org_study_id
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