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NCT04135833 Clinical Trial

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

NSCLC Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04135833
Other study ID # BPI-7711DDI
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date December 12, 2019
Est. completion date July 22, 2020

Study information
Verified date April 2021
Source Beta Pharma, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 31
Est. completion date July 22, 2020
Est. primary completion date July 22, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• BPI-7711
BPI-7711 60 mg
• BPI-7711
BPI-7711 180 mg
• Itraconazole
Itraconazole 200 mg
• Rifampicin
Rifampicin 600 mg

Locations
Country Name City State
China Shanghai Xuhui Central Hospital Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Beta Pharma, Inc.

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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