Pharmacokinetics in Healthy Volunteers
Conditions
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.
Interventions
DRUGPexidartinib
Orally, on Day 2
DRUGProbenecid
Orally, on Day 2
Sponsors
Daiichi Sankyo
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
This is an open-label, 2-treatment sequence, 2-period, crossover study with a washout between doses and treatment periods
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of participants experiencing an adverse event | within 312 hours post dose | Total number of participants experiencing any adverse event |
Countries
United States
Outcome results
None listed