A Phase I Study to Determine the Effect of Food on the Pharmacokinetic Profile of BPI-7711

An Open-label, Randomised, Single Dose, Cross-over Phase I Study to Determine the Effect of Food on the Pharmacokinetic Profile of BPI-7711

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.

Study Overview

• Status: Completed
• Conditions: NSCLC
• Intervention / Treatment: Drug: BPI-7711

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200025
    • Shanghai Ninth People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fasted; BPI-7711 following a period of fasting	Drug: BPI-7711; BPI-7711 180 mg; Other Names: BPI-7711 capsule
Experimental: High-fat meal; BPI-7711 following a high-fat meal.	Drug: BPI-7711; BPI-7711 180 mg; Other Names: BPI-7711 capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Pharmacokinetics of BPI-7711 by assessment of maximum plasma concentration	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
AUC(0-last)	Pharmacokinetics of BPI-7711 by assessment of area under the plasma concentration time curve from zero to last assessed timepoint	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

Collaborators and Investigators

• Sponsor: Beta Pharma, Inc.
• Investigators: Principal Investigator: Yongfang Yuan, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2019
• Primary Completion (Actual): March 25, 2020
• Study Completion (Actual): March 25, 2020

Study Registration Dates

• First Submitted: October 21, 2019
• First Submitted That Met QC Criteria: October 21, 2019
• First Posted (Actual): October 23, 2019

Study Record Updates

• Last Update Posted (Actual): July 9, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: BPI-7711FE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No