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

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

Study Overview

• Status: Completed
• Conditions: Solid Tumors
• Intervention / Treatment: Drug: Tesetaxel 10 mg with and then without food; Drug: Tesetaxel 10 mg without and then with food

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).

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • DaVita Clinical Researh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Treatment sequence 1; 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; Treatment Period 1: Tesetaxel 10 mg in the fed state; Treatment Period 2: Tesetaxel 10 mg in the fasted state
Other: Treatment sequence 2; 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; Treatment Period 1: Tesetaxel 10 mg in the fasted state; Treatment Period 2: Tesetaxel 10 mg in the fed state

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

Collaborators and Investigators

• Sponsor: Genta Incorporated
• Investigators: Principal Investigator: Harry W Alcorn, PharmD, Davita Clinical Research

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: July 26, 2010
• First Submitted That Met QC Criteria: July 27, 2010
• First Posted (Estimate): July 28, 2010

Study Record Updates

• Last Update Posted (Estimate): July 24, 2012
• Last Update Submitted That Met QC Criteria: July 20, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Advanced solid tumors
• Other Study ID Numbers: TOPK103