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Completed

NCT Number: NCT04135833

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

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.

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Key information

Conditions

NSCLC

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Shanghai Xuhui Central Hospital

Shanghai, 200000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BPI-7711

Drug

BPI-7711 60 mg

Other names: BPI-7711 capsule

Itraconazole

Drug

Itraconazole 200 mg

Other names: Itraconazole capsule

rifampicin

Drug

Rifampicin 600 mg

Other names: Rifampicin capsule

Primary outcomes

  1. Cmax

    Time frame: 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

  2. AUC(0-last)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Beta Pharma, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 23, 2019
Registry last updated
Apr 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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