Status:
COMPLETED
Effects of Food on the Pharmacokinetics of Tesetaxel 10 mg Capsules
Lead Sponsor:
Genta Incorporated
Conditions:
Solid Tumors
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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).
Eligibility Criteria
Inclusion
- Key inclusion criteria:
- Male or female subjects between 18 and 75 years of age.
- Histologically or cytologically confirmed advanced solid tumor malignancy.
- Negative serum pregnancy test within 7 days prior to the first dose of study drug in women of childbearing potential.
- 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.
- Body weight ≥ 50 kg for women and men and BMI within the range of 19 to 35 kg/m2 inclusive.
- 12-lead ECG without any clinically significant abnormality as judged by the Investigator.
- Able to swallow oral medication.
- Adequate organ system function.
- Key exclusion criteria:
- A positive pre-study hepatitis B surface antigen.
- Symptomatic or acute hepatic or biliary abnormalities.
- Clinically significant gastrointestinal abnormalities that increase the risk for perforation.
- Presence of uncontrolled infection.
- Positive pre-study drug/alcohol screen.
- 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).
- Current treatment with any cancer therapy that is causing significant gastrointestinal side effects, including but not limited to, nausea, vomiting, and diarrhea.
- 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.
- Pregnancy or lactation.
- Hypoalbuminemia (serum albumin \<3.0 g/dL) at screening.
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01170975
Start Date
June 1 2010
End Date
April 1 2011
Last Update
July 24 2012
Active Locations (1)
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1
DaVita Clinical Researh
Minneapolis, Minnesota, United States, 55404