Pharmacokinetics in Healthy Volunteers Clinical Trial
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
| Verified date | May 2017 |
| Source | Daiichi Sankyo Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 16 |
| Est. completion date | March 30, 2017 |
| Est. primary completion date | March 30, 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 60 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Worldwide Clinical Trials Early Phase Services | San Antonio | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Daiichi Sankyo Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maximum Plasma Concentration (Cmax) | Maximum concentration of the drug and its metabolite in plasma | predose to 312 hours post dose | |
| Primary | Time to Maximum Concentration (Tmax) | Time at which the maximum concentration is reached | within 312 hours post dose | |
| Primary | Area under the curve to the last quantifiable measurement (AUClast) | Area under the drug concentration time curve from the first measurement to the last | within 312 hours post dose | |
| Secondary | Number of participants experiencing an adverse event | Total number of participants experiencing any adverse event | within 312 hours post dose |