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

NCT ID: NCT00513253

Last Updated: 2015-02-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2008-05-31

Brief Summary

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

Conditions

Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

lapatinib

Intervention Type: DRUG

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 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Buffalo, New York, United States

Countries

United States

Other Identifiers

EGF101950

Identifier Type: -

Identifier Source: org_study_id