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NCT04135820 Clinical Trial

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
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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