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

Beta Pharma

Status and phase: Completed; Phase 1

Conditions: NSCLC

Treatments: Drug: BPI-7711

Study type: Interventional

Funder types: Industry

Identifiers

NCT04135820

BPI-7711FE

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Fasted

Experimental group

Description:

BPI-7711 following a period of fasting

Treatment:

Drug: BPI-7711

High-fat meal

Experimental group

Description:

BPI-7711 following a high-fat meal.

Treatment:

Drug: BPI-7711