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OpenTrials
Completed

NCT Number: NCT03138759

Effect of Probenecid on Pexidartinib Pharmacokinetics

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.

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Key information

Conditions

Pharmacokinetics in Healthy Volunteers

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Worldwide Clinical Trials Early Phase Services

San Antonio, Texas, 78217, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pexidartinib

Drug

Orally, on Day 2

Other names: Treatment A

Probenecid

Drug

Orally, on Day 2

Other names: Treatment B

Primary outcomes

  1. Maximum Plasma Concentration (Cmax)

    Time frame: predose to 312 hours post dose

    Maximum concentration of the drug and its metabolite in plasma

  2. Time to Maximum Concentration (Tmax)

    Time frame: within 312 hours post dose

    Time at which the maximum concentration is reached

  3. 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

Secondary outcomes

  1. Number of participants experiencing an adverse event

    Time frame: within 312 hours post dose

    Total number of participants experiencing any adverse event

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 3, 2017
Registry last updated
May 3, 2017

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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