Effects of Food on the Pharmacokinetics of Tesetaxel 10 mg Capsules
NCT ID: NCT01170975
Last Updated: 2012-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2010-06-30
2011-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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Treatment sequence 1
Treatment Period 1: Tesetaxel 10 mg in the fed state; Treatment Period 2: Tesetaxel 10 mg in the fasted state
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
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
18 Years
75 Years
ALL
No
Sponsors
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Genta Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Harry W Alcorn, PharmD
Role: PRINCIPAL_INVESTIGATOR
Davita Clinical Research
Locations
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DaVita Clinical Researh
Minneapolis, Minnesota, United States
Countries
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Other Identifiers
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TOPK103
Identifier Type: -
Identifier Source: org_study_id