A Phase I Study to Determine the Effect of Food on the Pharmacokinetic Profile of BPI-7711
NCT ID: NCT04135820
Last Updated: 2020-07-09
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
16 participants
INTERVENTIONAL
2019-12-17
2020-03-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Fasted
BPI-7711 following a period of fasting
BPI-7711
BPI-7711 180 mg
High-fat meal
BPI-7711 following a high-fat meal.
BPI-7711
BPI-7711 180 mg
Interventions
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BPI-7711
BPI-7711 180 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
55 Years
MALE
Yes
Sponsors
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Beta Pharma, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Yongfang Yuan
Role: PRINCIPAL_INVESTIGATOR
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Locations
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Shanghai Ninth People's Hospital
Shanghai, , China
Countries
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Other Identifiers
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BPI-7711FE
Identifier Type: -
Identifier Source: org_study_id
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