Healthy Subjects
Conditions
Keywords
lapatinib, Healthy Adult Volunteer
Brief summary
This study is designed to estimate the relative bioavailability of alternative lapatinib oral formulations compared to the current tablet formulation.
Interventions
DRUGlapatinib
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma levels for lapatinib will be done at: | Day 1, Day 2, Day 3 for each Treatment Period |
Secondary
| Measure | Time frame |
|---|---|
| Medical History | at screening |
| Physical Exam | at screening & follow-up (f/u) |
| Continuous Adverse Event monitoring | throughout the study |
| Vital Signs, ECGs, & Lab tests | at screening, Day 1, and f/u |
| Response to questionnaire regarding taste and aesthetics of suspension formulations under evaluation | — |
Countries
United States
Outcome results
None listed