Effects of Food on the Pharmacokinetics of Tesetaxel 10 mg Capsules

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genta Incorporated
ClinicalTrials.gov Identifier:
NCT01170975
First received: July 26, 2010
Last updated: July 20, 2012
Last verified: July 2012
  Purpose

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


Condition Intervention Phase
Solid Tumors
Drug: Tesetaxel 10 mg with and then without food
Drug: Tesetaxel 10 mg without and then with food
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Genta Incorporated:

Primary Outcome Measures:
  • Pharmacokinetic parameters [ Time Frame: Predose and postdosing up to 36 days after administration of each dose ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • Safety and tolerability [ Time Frame: From screening through 36 days after administration of the final dose ] [ Designated as safety issue: Yes ]
    Adverse events, clinical laboratory tests, vital signs


Enrollment: 12
Study Start Date: June 2010
Study Completion Date: April 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01170975

Locations
United States, Minnesota
DaVita Clinical Researh
Minneapolis, Minnesota, United States, 55404
Sponsors and Collaborators
Genta Incorporated
Investigators
Principal Investigator: Harry W Alcorn, PharmD Davita Clinical Research
  More Information

No publications provided

Responsible Party: Genta Incorporated
ClinicalTrials.gov Identifier: NCT01170975     History of Changes
Other Study ID Numbers: TOPK103
Study First Received: July 26, 2010
Last Updated: July 20, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Genta Incorporated:
Advanced solid tumors

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on July 29, 2014