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

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

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 Overview

• Status: Completed
• Conditions: NSCLC
• Intervention / Treatment: Drug: BPI-7711; Drug: BPI-7711; Drug: Itraconazole; Drug: Rifampicin

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200000
    • Shanghai Xuhui Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Itraconazole and BPI-7711; BPI-7711 alone followed by BPI-7711 +Itraconazole, followed by Itraconazole alone.	Drug: BPI-7711; BPI-7711 180 mg; Other Names: BPI-7711 capsule; Drug: BPI-7711; BPI-7711 60 mg; Other Names: BPI-7711 capsule; Drug: Itraconazole; Itraconazole 200 mg; Other Names: Itraconazole capsule
Experimental: Rifampicin and BPI-7711; BPI-7711 alone followed by BPI-7711 +Rifampicin, followed by Rifampicin alone.	Drug: BPI-7711; BPI-7711 180 mg; Other Names: BPI-7711 capsule; Drug: BPI-7711; BPI-7711 60 mg; Other Names: BPI-7711 capsule; Drug: Rifampicin; Rifampicin 600 mg; Other Names: Rifampicin capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Pharmacokinetics of BPI-7711 by assessment of maximum plasma concentration	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	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

Collaborators and Investigators

• Sponsor: Beta Pharma, Inc.
• Investigators: Principal Investigator: Jingying Jia, Shanghai Xuhui Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2019
• Primary Completion (Actual): July 22, 2020
• Study Completion (Actual): July 22, 2020

Study Registration Dates

• First Submitted: October 21, 2019
• First Submitted That Met QC Criteria: October 21, 2019
• First Posted (Actual): October 23, 2019

Study Record Updates

• Last Update Posted (Actual): April 22, 2021
• Last Update Submitted That Met QC Criteria: April 21, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Leprostatic Agents; Hormone Antagonists; Cytochrome P-450 Enzyme Inducers; Antifungal Agents; Steroid Synthesis Inhibitors; Cytochrome P-450 CYP3A Inducers; Antitubercular Agents; 14-alpha Demethylase Inhibitors; Antibiotics, Antitubercular; Cytochrome P-450 CYP2B6 Inducers; Cytochrome P-450 CYP2C8 Inducers; Cytochrome P-450 CYP2C19 Inducers; Cytochrome P-450 CYP2C9 Inducers; Rifampin; Itraconazole; Hydroxyitraconazole
• Other Study ID Numbers: BPI-7711DDI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No