Effects of Food on the Pharmacokinetics of Tesetaxel 10 mg Capsules

Study Overview
=================
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).

Official Title
-----------------
An Open-label, Single-dose, Randomized, Crossover Study to Determine the Effects of Food on the Pharmacokinetics of Tesetaxel 10 mg Capsule in Solid Tumor Cancer Subjects

Conditions
-----------------
Solid Tumors

Intervention / Treatment
-----------------
* Drug: Tesetaxel 10 mg with and then without food
* Drug: Tesetaxel 10 mg without and then with food


Participation Criteria
=================
Eligibility Criteria
-----------------
Key inclusion criteria: Male or female subjects between 18 and 75 years of age. Histologically or cytologically confirmed advanced solid tumor malignancy. Negative serum pregnancy test within 7 days prior to the first dose of study drug in women of childbearing potential. 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. Body weight ≥ 50 kg for women and men and BMI within the range of 19 to 35 kg/m2 inclusive. 12-lead ECG without any clinically significant abnormality as judged by the Investigator. Able to swallow oral medication. Adequate organ system function. Key exclusion criteria: A positive pre-study hepatitis B surface antigen. Symptomatic or acute hepatic or biliary abnormalities. Clinically significant gastrointestinal abnormalities that increase the risk for perforation. Presence of uncontrolled infection. Positive pre-study drug/alcohol screen. 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). Current treatment with any cancer therapy that is causing significant gastrointestinal side effects, including but not limited to, nausea, vomiting, and diarrhea. 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. Pregnancy or lactation. Hypoalbuminemia (serum albumin <3.0 g/dL) at screening. 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment sequence 1<br>Treatment Period 1: Tesetaxel 10 mg in the fed state; Treatment Period 2: Tesetaxel 10 mg in the fasted state | Drug: Tesetaxel 10 mg with and then without food<br>* Treatment Period 1: Tesetaxel 10 mg in the fed state; Treatment Period 2: Tesetaxel 10 mg in the fasted state<br>|
| Other: Treatment sequence 2<br>Treatment Period 1: Tesetaxel 10 mg in the fasted state; Treatment Period 2: Tesetaxel 10 mg in the fed state | Drug: Tesetaxel 10 mg without and then with food<br>* Treatment Period 1: Tesetaxel 10 mg in the fasted state; Treatment Period 2: Tesetaxel 10 mg in the fed state<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters | 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) | Predose and postdosing up to 36 days after administration of each dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability | Adverse events, clinical laboratory tests, vital signs | From screening through 36 days after administration of the final dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced solid tumors