NCT04135820

Brief Summary

This is an open-label, randomised, single-dose, cross-over phase I study to evaluate the effect of food on the pharmacokinetic profile of BPI-7711 in Chinese healthy male subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2019

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

December 17, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2020

Completed
Last Updated

July 9, 2020

Status Verified

July 1, 2020

Enrollment Period

3 months

First QC Date

October 21, 2019

Last Update Submit

July 7, 2020

Conditions

NSCLC

Outcome Measures

Primary Outcomes (2)

  • Cmax

    Pharmacokinetics of BPI-7711 by assessment of maximum plasma concentration

    Blood samples collected on Day 1 and Day 15 at pre-dose, 1, 2, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144 and 168 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 15 at pre-dose, 1, 2, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144 and 168 hours post BPI-7711 dose

Study Arms (2)

Fasted

EXPERIMENTAL

BPI-7711 following a period of fasting

Drug: BPI-7711

High-fat meal

EXPERIMENTAL

BPI-7711 following a high-fat meal.

Drug: BPI-7711

Interventions

BPI-7711DRUG

BPI-7711 180 mg

Also known as: BPI-7711 capsule
FastedHigh-fat meal

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male, aged from 18 to 55 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 Ninth People's Hospital

Shanghai, 200025, China

Location

MeSH Terms

Interventions

rezivertinib

Study Officials

  • Yongfang Yuan

    Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2019

First Posted

October 23, 2019

Study Start

December 17, 2019

Primary Completion

March 25, 2020

Study Completion

March 25, 2020

Last Updated

July 9, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)