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

Sponsor
Beta Pharma, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04135820
Collaborator
(none)
16
Enrollment
1
Location
2
Arms
3.3
Actual Duration (Months)
4.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official 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
Actual Study Start Date :
Dec 17, 2019
Actual Primary Completion Date :
Mar 25, 2020
Actual Study Completion Date :
Mar 25, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Fasted

BPI-7711 following a period of fasting

Drug: BPI-7711
BPI-7711 180 mg
Other Names:
  • BPI-7711 capsule

    		•
    Experimental: High-fat meal

    BPI-7711 following a high-fat meal.

    Drug: BPI-7711
    BPI-7711 180 mg
    Other Names:
  • BPI-7711 capsule

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Cmax [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) [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shanghai Ninth People's Hospital Shanghai China 200025

    Sponsors and Collaborators

    • Beta Pharma, Inc.

    Investigators

    • Principal Investigator: Yongfang Yuan, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Beta Pharma, Inc.
    ClinicalTrials.gov Identifier:
    NCT04135820
    Other Study ID Numbers:
    • BPI-7711FE
    First Posted:
    Oct 23, 2019
    Last Update Posted:
    Jul 9, 2020
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jul 9, 2020