A Phase I Study to Determine the Effect of Food on the Pharmacokinetic Profile of BPI-7711
- Registration Number
- NCT04135820
- Lead Sponsor
- Beta Pharma, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 16
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description High-fat meal BPI-7711 BPI-7711 following a high-fat meal. Fasted BPI-7711 BPI-7711 following a period of fasting
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Shanghai Ninth People's Hospital
🇨🇳Shanghai, China