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

Sponsor
Beta Pharma, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04135833
Collaborator
(none)
31
1
2
7.3
4.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
31 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
A Phase I Study to Assess the Effect of Itraconazole and Rifampicin on Pharmacokinetics Profile of BPI-7711 in Chinese Healthy Volunteers
Actual Study Start Date :
Dec 12, 2019
Actual Primary Completion Date :
Jul 22, 2020
Actual Study Completion Date :
Jul 22, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Itraconazole and BPI-7711

BPI-7711 alone followed by BPI-7711 +Itraconazole, followed by Itraconazole alone.

Drug: BPI-7711
BPI-7711 60 mg
Other Names:
  • BPI-7711 capsule
  • Drug: Itraconazole
    Itraconazole 200 mg
    Other Names:
  • Itraconazole capsule
  • Experimental: Rifampicin and BPI-7711

    BPI-7711 alone followed by BPI-7711 +Rifampicin, followed by Rifampicin alone.

    Drug: BPI-7711
    BPI-7711 180 mg
    Other Names:
  • BPI-7711 capsule
  • Drug: Rifampicin
    Rifampicin 600 mg
    Other Names:
  • Rifampicin capsule
  • Outcome Measures

    Primary Outcome Measures

    1. Cmax [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) [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shanghai Xuhui Central Hospital Shanghai China 200000

    Sponsors and Collaborators

    • Beta Pharma, Inc.

    Investigators

    • Principal Investigator: Jingying Jia, Shanghai Xuhui Central Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Beta Pharma, Inc.
    ClinicalTrials.gov Identifier:
    NCT04135833
    Other Study ID Numbers:
    • BPI-7711DDI
    First Posted:
    Oct 23, 2019
    Last Update Posted:
    Apr 22, 2021
    Last Verified:
    Apr 1, 2021
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 22, 2021