NSCLC
Conditions
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.
Interventions
DRUGBPI-7711
BPI-7711 180 mg
Sponsors
Beta Pharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | Blood samples collected on Day 1 and Day 15 at pre-dose, 1, 2, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144 and 168 hours post BPI-7711 dose | Pharmacokinetics of BPI-7711 by assessment of maximum plasma concentration |
| AUC(0-last) | Blood samples collected on Day 1 and Day 15 at pre-dose, 1, 2, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144 and 168 hours post BPI-7711 dose | Pharmacokinetics of BPI-7711 by assessment of area under the plasma concentration time curve from zero to last assessed timepoint |
Countries
China
Outcome results
None listed