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

Beta Pharma, Inc.16 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

NSCLC

Interventions

BPI-7711DRUG

BPI-7711 180 mg

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Shanghai Ninth People's Hospital

Shanghai, China

Outcomes

Primary Outcomes

Cmax

Pharmacokinetics of BPI-7711 by assessment of maximum plasma concentration

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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