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

July 26, 2010
July 20, 2012
June 2010
February 2011   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01170975 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
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.

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).

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Solid Tumors
  • 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
  • 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
  • Treatment sequence 1
    Treatment Period 1: Tesetaxel 10 mg in the fed state; Treatment Period 2: Tesetaxel 10 mg in the fasted state
    Intervention: Drug: Tesetaxel 10 mg with and then without food
  • Treatment sequence 2
    Treatment Period 1: Tesetaxel 10 mg in the fasted state; Treatment Period 2: Tesetaxel 10 mg in the fed state
    Intervention: Drug: Tesetaxel 10 mg without and then with food
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
April 2011
February 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01170975
TOPK103
No
Genta Incorporated
Genta Incorporated
Not Provided
Principal Investigator: Harry W Alcorn, PharmD Davita Clinical Research
Genta Incorporated
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP