Effects of Food on the Pharmacokinetics of Tesetaxel 10 mg Capsules

Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01170975
• Other study ID #: TOPK103
• Status: Completed
• Phase: Phase 1
• First received: July 26, 2010
• Last updated: July 20, 2012
• Start date: June 2010
• Est. completion date: April 2011

Study information

• Verified date: July 2012
• Source: Genta Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Solid Tumors

Intervention

Drug:
• Tesetaxel 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
• Tesetaxel 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

Locations

Country	Name	City	State
United States	DaVita Clinical Researh	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Genta Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Safety and tolerability	Adverse events, clinical laboratory tests, vital signs	From screening through 36 days after administration of the final dose	Yes