Clinical trial NCT00513253: A Phase I Study to Test Alternate Oral Formulations vs the Current Tablet Formulation of Lapatinib
Official title: Relative Bioavailability of Four Alternative Oral Formulations Versus the Current Tablet Formulation of Lapatinib
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: lapatinib
Healthy Adult Volunteer
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-08-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is designed to estimate the relative bioavailability of alternative lapatinib oral formulations compared to the current tablet formulation.


Eligibility criteria: Inclusion Criteria:

* The subject is healthy as defined per protocol.
* The subject is male or female.

  * A female is eligible to enter and participate in this study if she is of:
* Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who:
* Has had a documented (medical report verification) hysterectomy or double oophorectomy or
* Is 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy or
* 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 :
* 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.
* Vasectomized partner
* Intrauterine device (IUD) with a documented failure rate of less than 1% per year.
* Double-barrier contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm).
* Hormonal contraceptive plus male condom.
* Age: 18 to 60 years inclusive.
* BMI within the range 19 to 31.0 kg/m2.
* Able to swallow and retain oral medication.
* The subject is willing to refrain from the use of illicit drugs and adhere to other protocol-stated restrictions while participating in the study.
* The subject is able to understand and comply with protocol requirements and instructions and is likely to complete the study as planned.
* A signed and dated written informed consent is obtained from the subject or the subject's legally acceptable representative prior to screening.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Plasma levels for lapatinib will be done at:
timeFrame: Day 1, Day 2, Day 3 for each Treatment Period
Secondary outcomes:
measure: Medical History
timeFrame: at screening
measure: Physical Exam
timeFrame: at screening & follow-up (f/u)
measure: Continuous Adverse Event monitoring
timeFrame: throughout the study
measure: Vital Signs, ECGs, & Lab tests
timeFrame: at screening, Day 1, and f/u
measure: Response to questionnaire regarding taste and aesthetics of suspension formulations under evaluation
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: GSK Investigational Site
state: New York
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: