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

Phase 1

Completed

• Conditions: NSCLC
• Interventions: Drug: BPI-7711; Drug: Itraconazole; Drug: Rifampicin

• Registration Number: NCT04135833
• Lead Sponsor: Beta Pharma, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-21
• Study First Submitted QC: 2019-10-21
• Study First Posted: 2019-10-23
• Study Start: 2019-12-12
• Primary Completion: 2020-07-22
• Study Completion: 2020-07-22
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-21
• Last Update Posted: 2021-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Itraconazole and BPI-7711	BPI-7711	BPI-7711 alone followed by BPI-7711 +Itraconazole, followed by Itraconazole alone.
Itraconazole and BPI-7711	Itraconazole	BPI-7711 alone followed by BPI-7711 +Itraconazole, followed by Itraconazole alone.
Rifampicin and BPI-7711	BPI-7711	BPI-7711 alone followed by BPI-7711 +Rifampicin, followed by Rifampicin alone.
Rifampicin and BPI-7711	Rifampicin	BPI-7711 alone followed by BPI-7711 +Rifampicin, followed by Rifampicin alone.

Primary Outcome Measures

Name	Time	Method
Cmax	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	Pharmacokinetics of BPI-7711 by assessment of maximum plasma concentration
AUC(0-last)	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	Pharmacokinetics of BPI-7711 by assessment of area under the plasma concentration time curve from zero to last assessed timepoint

Trial Locations

Locations (1)

Shanghai Xuhui Central Hospital; 🇨🇳 Shanghai, China