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Completed

NCT Number: NCT04135820

A Phase I Study to Determine the Effect of Food on the Pharmacokinetic Profile of BPI-7711

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.

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Key information

Conditions

NSCLC

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Shanghai Ninth People's Hospital

Shanghai, 200025, 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 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.

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 180 mg

Other names: BPI-7711 capsule

Primary outcomes

  1. Cmax

    Time frame: 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

    Pharmacokinetics of BPI-7711 by assessment of maximum plasma concentration

  2. AUC(0-last)

    Time frame: 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

    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

An Open-label, Randomised, Single Dose, Cross-over Phase I Study to Determine the Effect of Food on the Pharmacokinetic Profile of BPI-7711

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 23, 2019
Registry last updated
Jul 9, 2020

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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