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

Healthy Subjects Clinical Trial

Official title:

Relative Bioavailability of Four Alternative Oral Formulations Versus the Current Tablet Formulation of Lapatinib

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00513253
• Other study ID #: EGF101950
• Status: Withdrawn
• Phase: Phase 1
• First received: August 6, 2007
• Last updated: February 12, 2015
• Start date: April 2008
• Est. completion date: May 2008

Study information

• Verified date: February 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• lapatinib

Locations

Country	Name	City	State
United States	GSK Investigational Site	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma levels for lapatinib will be done at:		Day 1, Day 2, Day 3 for each Treatment Period
Secondary	Medical History		at screening
Secondary	Physical Exam		at screening & follow-up (f/u)
Secondary	Continuous Adverse Event monitoring		throughout the study
Secondary	Vital Signs, ECGs, & Lab tests		at screening, Day 1, and f/u
Secondary	Response to questionnaire regarding taste and aesthetics of suspension formulations under evaluation