A Phase I Study to Assess the Effect of Itraconazole and Rifampicin on Pharmacokinetics Profile of BPI-7711
1 other identifier
interventional
31
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Dec 2019
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2019
CompletedFirst Posted
Study publicly available on registry
October 23, 2019
CompletedStudy Start
First participant enrolled
December 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 22, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 22, 2020
CompletedApril 22, 2021
April 1, 2021
7 months
October 21, 2019
April 21, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
Itraconazole and BPI-7711
EXPERIMENTALBPI-7711 alone followed by BPI-7711 +Itraconazole, followed by Itraconazole alone.
Rifampicin and BPI-7711
EXPERIMENTALBPI-7711 alone followed by BPI-7711 +Rifampicin, followed by Rifampicin alone.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Xuhui Central Hospital
Shanghai, 200000, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jingying Jia
Shanghai Xuhui Central Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2019
First Posted
October 23, 2019
Study Start
December 12, 2019
Primary Completion
July 22, 2020
Study Completion
July 22, 2020
Last Updated
April 22, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share