Effects of Food on the Pharmacokinetics of Tesetaxel 10 mg Capsules

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

Sponsors

Lead Sponsor: Genta Incorporated

Source Genta Incorporated
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).

Overall Status Completed
Start Date June 2010
Completion Date April 2011
Primary Completion Date February 2011
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Pharmacokinetic parameters Predose and postdosing up to 36 days after administration of each dose
Secondary Outcome
Measure Time Frame
Safety and tolerability From screening through 36 days after administration of the final dose
Enrollment 12
Condition
Intervention

Intervention Type: Drug

Intervention Name: Tesetaxel 10 mg with and then without food

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

Arm Group Label: Treatment sequence 1

Intervention Type: Drug

Intervention Name: Tesetaxel 10 mg without and then with food

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

Arm Group Label: Treatment sequence 2

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Harry W Alcorn, PharmD Principal Investigator Davita Clinical Research
Location
Facility: DaVita Clinical Researh
Location Countries

United States

Verification Date

July 2012

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Label: Treatment sequence 1

Type: Other

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

Label: Treatment sequence 2

Type: Other

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

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Masking: None (Open Label)

Source: ClinicalTrials.gov