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

NSCLC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04135820
• Other study ID #: BPI-7711FE
• Status: Completed
• Phase: Phase 1
• Start date: December 17, 2019
• Est. completion date: March 25, 2020

Study information

• Verified date: July 2020
• Source: Beta Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 25, 2020
• Est. primary completion date: March 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• NSCLC

Intervention

Drug:
• BPI-7711
BPI-7711 180 mg

Locations

Country	Name	City	State
China	Shanghai Ninth People's Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Beta Pharma, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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