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

NCT00513253 | Withdrawn Phase 1

• 1 other identifier: EGF101950
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

lapatinib; Healthy Adult Volunteer

Outcome Measures

Primary Outcomes (1)

• Plasma levels for lapatinib will be done at:

  Day 1, Day 2, Day 3 for each Treatment Period

Secondary Outcomes (5)

• 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

Interventions

lapatinib DRUG

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Buffalo, New York, 14202, United States

Location

MeSH Terms

Interventions

Lapatinib

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2007
• First Posted: August 8, 2007
• Study Start: April 1, 2008
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: February 16, 2015

Record last verified: 2015-02

Locations

US (1)