A Phase I Study to Assess the Effect of Itraconazole and Rifampicin on Pharmacokinetics Profile of BPI-7711
NCT ID: NCT04135833
Last Updated: 2021-04-22
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
31 participants
INTERVENTIONAL
2019-12-12
2020-07-22
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
OTHER
NONE
Study Groups
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Itraconazole and BPI-7711
BPI-7711 alone followed by BPI-7711 +Itraconazole, followed by Itraconazole alone.
BPI-7711
BPI-7711 60 mg
Itraconazole
Itraconazole 200 mg
Rifampicin and BPI-7711
BPI-7711 alone followed by BPI-7711 +Rifampicin, followed by Rifampicin alone.
BPI-7711
BPI-7711 180 mg
Rifampicin
Rifampicin 600 mg
Interventions
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BPI-7711
BPI-7711 60 mg
BPI-7711
BPI-7711 180 mg
Itraconazole
Itraconazole 200 mg
Rifampicin
Rifampicin 600 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMI from 18.5 to 28.0 kg/m2
* Medical history, vital signs, physical examination and lab tests are normal or abnormal without clinical significance
Exclusion Criteria
* Subjects with allergic disease history
* Subjects with gastrointestinal disease history that can affect study drug absorption
* Subjects with drug abuse history
18 Years
45 Years
MALE
Yes
Sponsors
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Beta Pharma, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jingying Jia
Role: PRINCIPAL_INVESTIGATOR
Shanghai Xuhui Central Hospital
Locations
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Shanghai Xuhui Central Hospital
Shanghai, , China
Countries
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Other Identifiers
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BPI-7711DDI
Identifier Type: -
Identifier Source: org_study_id
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