A Phase I Study to Assess the Effect of Itraconazole and Rifampicin on Pharmacokinetics Profile of BPI-7711

Beta Pharma, Inc.31 enrolled

Overview

This is a phase I study to assess the effect of itraconazole and rifampicin on the pharmacokinetic parameters of BPI-7711 in Chinese healthy volunteers.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

NSCLC

Interventions

BPI-7711DRUG

BPI-7711 60 mg

BPI-7711DRUG

BPI-7711 180 mg

ItraconazoleDRUG

Itraconazole 200 mg

Rifampicin

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male, aged from 18 to 45 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 Xuhui Central 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 20 (arm 1)/Day 25 (arm 2) at pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168 and 336 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 20 (arm 1)/Day 25 (arm 2) at pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168 and 336 hours post BPI-7711 dose

Data from ClinicalTrials.gov

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