Clinical trial NCT01170975: Effects of Food on the Pharmacokinetics of Tesetaxel 10 mg Capsules
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumors
Keywords: Advanced solid tumors
Lead sponsor: Genta Incorporated
Sponsor class: INDUSTRY
First posted: 2010-07-28
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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).

Eligibility 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.

Primary outcomes:
measure: Pharmacokinetic parameters
timeFrame: Predose and postdosing up to 36 days after administration of each dose
Secondary outcomes:
measure: Safety and tolerability
timeFrame: From screening through 36 days after administration of the final dose
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: DaVita Clinical Researh
state: Minnesota
Study officials:
affiliation: Davita Clinical Research
name: Harry W Alcorn, PharmD
role: PRINCIPAL_INVESTIGATOR
References: