Status:
COMPLETED
A Phase I Study to Assess the Effect of Itraconazole and Rifampicin on Pharmacokinetics Profile of BPI-7711
Lead Sponsor:
Beta Pharma, Inc.
Conditions:
NSCLC
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
This is a phase I study to assess the effect of itraconazole and rifampicin on the pharmacokinetic parameters of BPI-7711 in Chinese healthy volunteers.
Eligibility Criteria
Inclusion
- Male, aged from 18 to 45 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 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 22 2020
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04135833
Start Date
December 12 2019
End Date
July 22 2020
Last Update
April 22 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Shanghai Xuhui Central Hospital
Shanghai, China, 200000