A Phase I Study to Test Alternate Oral Formulations vs the Current Tablet Formulation of Lapatinib
- Conditions
- Healthy Subjects
- Registration Number
- NCT00513253
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
This study is designed to estimate the relative bioavailability of alternative lapatinib oral formulations compared to the current tablet formulation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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The subject is healthy as defined per protocol.
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The subject is male or female.
- A female is eligible to enter and participate in this study if she is of:
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Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who:
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Has had a documented (medical report verification) hysterectomy or double oophorectomy or
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Is 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy or
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Is post-menopausal (defined as females older than 45 years of age with 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels higher than 40 mIU/ml)
- Childbearing potential, has a negative serum pregnancy test at Screening, and agrees to one of the following :
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Complete abstinence from sexual intercourse from two weeks prior to administration of the study drug and throughout the study, and through the follow-up visit which will occur within 10 to 14 days after completion of the last treatment.
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Vasectomized partner
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Intrauterine device (IUD) with a documented failure rate of less than 1% per year.
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Double-barrier contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm).
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Hormonal contraceptive plus male condom.
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Age: 18 to 60 years inclusive.
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BMI within the range 19 to 31.0 kg/m2.
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Able to swallow and retain oral medication.
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The subject is willing to refrain from the use of illicit drugs and adhere to other protocol-stated restrictions while participating in the study.
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The subject is able to understand and comply with protocol requirements and instructions and is likely to complete the study as planned.
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A signed and dated written informed consent is obtained from the subject or the subject's legally acceptable representative prior to screening.
- As a result of the medical interview, physical examination or screening investigations, the Principal Investigator considers the subject unfit for the study.
- The subject meets ECG-related exclusion criteria listed in the protocol or has serum magnesium or potassium below the normal range at screening.
- The subject has a history of drug or other allergy, which, in the opinion of the Principal Investigator, contraindicates participation.
- The subject has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study drug, including but not limited to Tarceva (erlotinib) or Iressa (gefitinib).
- The subject has a history of sensitivity to heparin or heparin-induced thrombocytopenia (applicable if heparin is used during pharmacokinetic sampling).
- The subject participated in a study with a new molecular entity or any other trial during the previous 30 days.
- The subject donated blood in excess of 500 mL within 56 days prior to dosing or intends to donate in the month after completing the study.
- Use of prescription or non-prescription drugs (including vitamins and herbal supplements) within two weeks prior to dosing or during the study, however, acetaminophen up to two grams per day is acceptable.
- History of alcohol/drug abuse or dependence within 12 months of the study as per protocol.
- The subject is a smoker or has smoked in the last four months.
- The subject tested positive for hepatitis C antibody, hepatitis B surface antigen, or HIV antibody.
- The subject has a positive urine test for drugs of abuse or is positive for alcohol use at pre-study screening.
- Consumption of red wine, Seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication until collection of the final PK blood sample.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Plasma levels for lapatinib will be done at: Day 1, Day 2, Day 3 for each Treatment Period
- Secondary Outcome Measures
Name Time Method Response to questionnaire regarding taste and aesthetics of suspension formulations under evaluation Medical History at screening Vital Signs, ECGs, & Lab tests at screening, Day 1, and f/u Physical Exam at screening & follow-up (f/u) Continuous Adverse Event monitoring throughout the study
Trial Locations
- Locations (1)
GSK Investigational Site
🇺🇸Buffalo, New York, United States