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

Beta Pharma

Status and phase: Completed; Phase 1

Conditions: NSCLC

Treatments: Drug: Rifampicin; Drug: Itraconazole; Drug: BPI-7711

Study type: Interventional

Funder types: Industry

Identifiers

NCT04135833

BPI-7711DDI

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Itraconazole and BPI-7711

Experimental group

Description:

BPI-7711 alone followed by BPI-7711 +Itraconazole, followed by Itraconazole alone.

Treatment:

Drug: BPI-7711

Drug: Itraconazole

Drug: BPI-7711

Rifampicin and BPI-7711

Experimental group

Description:

BPI-7711 alone followed by BPI-7711 +Rifampicin, followed by Rifampicin alone.

Treatment:

Drug: BPI-7711

Drug: Rifampicin

Drug: BPI-7711