Effect of Probenecid on Pexidartinib Pharmacokinetics

May 1, 2017 updated by: Daiichi Sankyo, Inc.

An Open-label, Randomized, 2-treatment, 2-period, Crossover Study to Evaluate the Effect of Probenecid on the Pharmacokinetics of Pexidartinib in Healthy Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78217
        • Worldwide Clinical Trials Early Phase Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Plasma Concentration (Cmax)
Time Frame: predose to 312 hours post dose
Maximum concentration of the drug and its metabolite in plasma
predose to 312 hours post dose
Time to Maximum Concentration (Tmax)
Time Frame: within 312 hours post dose
Time at which the maximum concentration is reached
within 312 hours post dose
Area under the curve to the last quantifiable measurement (AUClast)
Time Frame: within 312 hours post dose
Area under the drug concentration time curve from the first measurement to the last
within 312 hours post dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants experiencing an adverse event
Time Frame: within 312 hours post dose
Total number of participants experiencing any adverse event
within 312 hours post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2017

Primary Completion (Actual)

March 30, 2017

Study Completion (Actual)

March 30, 2017

Study Registration Dates

First Submitted

April 28, 2017

First Submitted That Met QC Criteria

May 1, 2017

First Posted (Actual)

May 3, 2017

Study Record Updates

Last Update Posted (Actual)

May 3, 2017

Last Update Submitted That Met QC Criteria

May 1, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PL3397-A-U122

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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