A Phase I Study to Test Alternate Oral Formulations vs the Current Tablet Formulation of Lapatinib

This study has suspended participant recruitment.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00513253
First received: August 6, 2007
Last updated: October 9, 2008
Last verified: October 2008
  Purpose

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


Condition Intervention Phase
Healthy Subjects
Drug: lapatinib
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Relative Bioavailability of Four Alternative Oral Formulations Versus the Current Tablet Formulation of Lapatinib

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Plasma levels for lapatinib will be done at: [ Time Frame: Day 1, Day 2, Day 3 for each Treatment Period ]

Secondary Outcome Measures:
  • Medical History [ Time Frame: at screening ]
  • Physical Exam [ Time Frame: at screening & follow-up (f/u) ]
  • Continuous Adverse Event monitoring [ Time Frame: throughout the study ]
  • Vital Signs, ECGs, & Lab tests [ Time Frame: at screening, Day 1, and f/u ]
  • Response to questionnaire regarding taste and aesthetics of suspension formulations under evaluation

Estimated Enrollment: 36
Study Start Date: April 2008
Estimated Study Completion Date: May 2008
Estimated Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: lapatinib
    Other Name: lapatinib
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00513253

Locations
United States, New York
GSK Investigational Site
Buffalo, New York, United States, 14202
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00513253     History of Changes
Other Study ID Numbers: EGF101950
Study First Received: August 6, 2007
Last Updated: October 9, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Healthy Adult Volunteer
lapatinib

Additional relevant MeSH terms:
Lapatinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014