Status:
COMPLETED
A Phase I Study to Determine the Effect of Food on the Pharmacokinetic Profile of BPI-7711
Lead Sponsor:
Beta Pharma, Inc.
Conditions:
NSCLC
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
This is an open-label, randomised, single-dose, cross-over phase I study to evaluate the effect of food on the pharmacokinetic profile of BPI-7711 in Chinese healthy male subjects.
Eligibility Criteria
Inclusion
- Male, aged from 18 to 55 years.
- 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
- Subjects with clinical significant diseases
- Subjects with allergic disease history
- Subjects with gastrointestinal disease history that can affect study drug absorption
- Subjects with drug abuse history
Key Trial Info
Start Date :
December 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2020
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04135820
Start Date
December 17 2019
End Date
March 25 2020
Last Update
July 9 2020
Active Locations (1)
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1
Shanghai Ninth People's Hospital
Shanghai, China, 200025