Effect of Probenecid on Pexidartinib Pharmacokinetics
- Conditions
- Pharmacokinetics in Healthy Volunteers
- Interventions
- Registration Number
- NCT03138759
- Lead Sponsor
- Daiichi Sankyo
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Pexidartinib then Probenecid Probenecid Participants receive Sequence AB: Treatment A (pexidartinib) first, then Treatment B (probenecid), with a washout period between them Probenecid then Pexidartinib Pexidartinib Participants receive Sequence BA: Treatment B (probenecid) first, then Treatment A (pexidartinib), with a washout period between them Probenecid then Pexidartinib Probenecid Participants receive Sequence BA: Treatment B (probenecid) first, then Treatment A (pexidartinib), with a washout period between them Pexidartinib then Probenecid Pexidartinib Participants receive Sequence AB: Treatment A (pexidartinib) first, then Treatment B (probenecid), with a washout period between them
- Primary Outcome Measures
Name Time Method Maximum Plasma Concentration (Cmax) predose to 312 hours post dose Maximum concentration of the drug and its metabolite in plasma
Time to Maximum Concentration (Tmax) within 312 hours post dose Time at which the maximum concentration is reached
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
Name Time Method Number of participants experiencing an adverse event within 312 hours post dose Total number of participants experiencing any adverse event
Trial Locations
- Locations (1)
Worldwide Clinical Trials Early Phase Services
🇺🇸San Antonio, Texas, United States