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Effect of Probenecid on Pexidartinib Pharmacokinetics

Sponsor
Daiichi Sankyo, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03138759
Collaborator
(none)
16
Enrollment
1
Location
2
Arms
1
Actual Duration (Months)
15.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this trial is to assess the effect of probenecid on the pharmacokinetics (PK) of single-dose pexidartinib in healthy subjects.

Secondary objectives are to assess the safety and tolerability of pexidartinib alone and in combination with probenecid.

Participants will be confined to the clinic for approximately 32 days. Blood samples will be collected for PK analysis of pexidartinib and metabolites at predose and up to 312 hours (h) post dose.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
This is an open-label, 2-treatment sequence, 2-period, crossover study with a washout between doses and treatment periodsThis is an open-label, 2-treatment sequence, 2-period, crossover study with a washout between doses and treatment periods
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
An Open-label, Randomized, 2-treatment, 2-period, Crossover Study to Evaluate the Effect of Probenecid on the Pharmacokinetics of Pexidartinib in Healthy Subjects
Actual Study Start Date :
Feb 27, 2017
Actual Primary Completion Date :
Mar 30, 2017
Actual Study Completion Date :
Mar 30, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pexidartinib then Probenecid

Participants receive Sequence AB: Treatment A (pexidartinib) first, then Treatment B (probenecid), with a washout period between them

Drug: Pexidartinib
Orally, on Day 2
Other Names:
  • Treatment A

    • Drug: Probenecid
    Orally, on Day 2
    Other Names:
  • Treatment B

    		•
    Experimental: Probenecid then Pexidartinib

    Participants receive Sequence BA: Treatment B (probenecid) first, then Treatment A (pexidartinib), with a washout period between them

    Drug: Pexidartinib
    Orally, on Day 2
    Other Names:
  • Treatment A

    • Drug: Probenecid
    Orally, on Day 2
    Other Names:
  • Treatment B

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum Plasma Concentration (Cmax) [predose to 312 hours post dose]

      Maximum concentration of the drug and its metabolite in plasma

    2. Time to Maximum Concentration (Tmax) [within 312 hours post dose]

      Time at which the maximum concentration is reached

    3. Area under the curve to the last quantifiable measurement (AUClast) [within 312 hours post dose]

      Area under the drug concentration time curve from the first measurement to the last

    Secondary Outcome Measures

    1. Number of participants experiencing an adverse event [within 312 hours post dose]

      Total number of participants experiencing any adverse event

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Is a healthy, nonsmoking person with a body mass index of 18 kg/m2 to 30 kg/m2 (inclusive) at Screening

    • Is willing to be confined at the clinic for approximately 32 days

    • Is surgically sterile or a naturally postmenopausal female and not lactating, or a male who agrees to use double barrier methods of contraception and avoid donating sperm from Check-in until 90 d after the final dose of pexidartinib

    Exclusion Criteria:
    • Has any history or condition, per protocol or in the opinion of the investigator, that might compromise the participant's safety, their ability to complete the trial, and or analysis of results

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Worldwide Clinical Trials Early Phase Services San Antonio Texas United States 78217

    Sponsors and Collaborators

    • Daiichi Sankyo, Inc.

    Investigators

    • Study Director: Clinical Study Leader, Daiichi Sankyo, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Daiichi Sankyo, Inc.
    ClinicalTrials.gov Identifier:
    NCT03138759
    Other Study ID Numbers:
    • PL3397-A-U122
    First Posted:
    May 3, 2017
    Last Update Posted:
    May 3, 2017
    Last Verified:
    May 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Probenecid

    Study Results

    No Results Posted as of May 3, 2017