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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014