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Healthy SubjectsPhase 1NCT00513253

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

A Phase 1 study testing lapatinib in people with Healthy Subjects, run by GlaxoSmithKline at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Subjects
What is being tested?
lapatinib
How many people
0 participants
Where
1 siteUnited States
Study dates
Apr 2008to May 2008
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • GSK Investigational Site

    Buffalo, New York, 14202

Other trials in United States

About this study

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

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

Being tested
lapatinib
Keywords
lapatinib, Healthy Adult Volunteer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lapatinibDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Plasma levels for lapatinib will be done at:

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

Secondary outcomes (5)

  1. Medical History

    Measured: at screening

  2. Physical Exam

    Measured: at screening & follow-up (f/u)

  3. Continuous Adverse Event monitoring

    Measured: throughout the study

  4. Vital Signs, ECGs, & Lab tests

    Measured: at screening, Day 1, and f/u

  5. Response to questionnaire regarding taste and aesthetics of suspension formulations under evaluation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2007 (estimated)
  2. Study startApr 2008
  3. Primary completionMay 2008 (estimated)
  4. Study completionMay 2008 (estimated)

Why it stopped: It was determined not to be needed based on the clinical development plan of Tykerb.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00513253
Sponsor's protocol ID
EGF101950
Status last verified
Feb 2015
First submitted
6 Aug 2007
Last updated
16 Feb 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing lapatinib in people with Healthy Subjects, run by GlaxoSmithKline at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 16 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasma levels for lapatinib will be done at: (time frame: Day 1, Day 2, Day 3 for each Treatment Period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00513253.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2015.

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Clinical Trial NCT00513253 | AzTrials