Solid Tumors
Conditions
Keywords
Advanced solid tumors
Brief summary
This study explores the effects of food (a high-fat meal) on the pharmacokinetics of tesetaxel.
Detailed description
This study is being conducted to determine whether the pharmacokinetics of a single dose of tesetaxel administered as a capsule is affected by co-administration with food (a high-fat meal).
Interventions
DRUGTesetaxel 10 mg with and then without food
Treatment Period 1: Tesetaxel 10 mg in the fed state; Treatment Period 2: Tesetaxel 10 mg in the fasted state
DRUGTesetaxel 10 mg without and then with food
Treatment Period 1: Tesetaxel 10 mg in the fasted state; Treatment Period 2: Tesetaxel 10 mg in the fed state
Sponsors
Genta Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key inclusion criteria: 1. Male or female subjects between 18 and 75 years of age. 2. Histologically or cytologically confirmed advanced solid tumor malignancy. 3. Negative serum pregnancy test within 7 days prior to the first dose of study drug in women of childbearing potential. 4. Agreement to use a highly effective form of contraception throughout the treatment phase of the study in women of childbearing potential and sexually active men. 5. Body weight ≥ 50 kg for women and men and BMI within the range of 19 to 35 kg/m2 inclusive. 6. 12-lead ECG without any clinically significant abnormality as judged by the Investigator. 7. Able to swallow oral medication. 8. Adequate organ system function. Key
Exclusion criteria
1. A positive pre-study hepatitis B surface antigen. 2. Symptomatic or acute hepatic or biliary abnormalities. 3. Clinically significant gastrointestinal abnormalities that increase the risk for perforation. 4. Presence of uncontrolled infection. 5. Positive pre-study drug/alcohol screen. 6. Treatment with an investigational agent within the following time periods prior to the first dose of study drug: 30 days, 5 half-lives, or twice the duration of the biological effect of the investigational product (whichever is longest). 7. Current treatment with any cancer therapy that is causing significant gastrointestinal side effects, including but not limited to, nausea, vomiting, and diarrhea. 8. Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with a subject's safety, obtaining informed consent, or compliance with the study. 9. Pregnancy or lactation. 10. Hypoalbuminemia (serum albumin \<3.0 g/dL) at screening. 11. Consumption of red wine, seville oranges, grapefruit or grapefruit juice, and/or pummelos, exotic citrus fruits, or grapefruit hybrids within 14 days prior to the first dose of study drug.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic parameters | Predose and postdosing up to 36 days after administration of each dose | Pharmacokinetic parameters include the area under the blood concentration-time curve (AUC0-inf, AUC0-t), concentration 24 h post dose (C24), maximum blood concentration (Cmax), time to maximum blood concentration (Tmax), terminal half-life (t½), and oral clearance (CL/F) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability | From screening through 36 days after administration of the final dose | Adverse events, clinical laboratory tests, vital signs |
Countries
United States
Outcome results
None listed