Effects of Food on the Pharmacokinetics of Tesetaxel 10 mg Capsules

Genta Incorporated

Status and phase: Completed; Phase 1

Conditions: Solid Tumors

Treatments: Drug: Tesetaxel 10 mg without and then with food; Drug: Tesetaxel 10 mg with and then without food

Study type: Interventional

Funder types: Industry

Identifiers

NCT01170975

TOPK103

Details and patient eligibility

About

This study explores the effects of food (a high-fat meal) on the pharmacokinetics of tesetaxel.

Full 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).

Enrollment: 12 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

12 participants in 2 patient groups

Treatment sequence 1

Other group

Description:

Treatment Period 1: Tesetaxel 10 mg in the fed state; Treatment Period 2: Tesetaxel 10 mg in the fasted state

Treatment:

Drug: Tesetaxel 10 mg with and then without food

Treatment sequence 2

Other group

Description:

Treatment Period 1: Tesetaxel 10 mg in the fasted state; Treatment Period 2: Tesetaxel 10 mg in the fed state

Treatment:

Drug: Tesetaxel 10 mg without and then with food