Last updated: 11/07/2018 08:33:31
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.

Absolute Bioavialability of GSK1120212

GSK study ID
115064
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Determination of the Absolute Bioavailability of GSK1120212 Following a Single Oral Dose Co-Administered with an Intravenous Radiolabelled Microdose of GSK1120212 in Subjects with solid Tumors
Trial description: A Phase I, single-center, open-label, single-persiod, combined single dose oral and IV microtracer study in subjects with solid tumors.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Determine the the absolute bioavailability of GSK1120212 following single oral tablet dose co-administered with an IV microdose.

Timeframe: Pre-dose, 0.5h, 1h, 1.5h, 1.55h, 1.75h,2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 24h, 48h, 72h, 120h, 168h, and 240h.

Secondary outcomes:

Determine the single dose PK of GSK1120212 following oral administration.

Timeframe: Pre-dose, 0.5h, 1h, 1.5h, 1.75h,2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 24h, 48h, 72h, 120h, 168h, and 240h.

Determine the single dose PK of GSK1120212 following IV administration.

Timeframe: 1.55h, 1.75h,2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 24h, 48h, 72h, 120h, 168h, and 240h.

AEs

Timeframe: Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 11, and follow-up.

Blood pressure

Timeframe: Screening, Day 1, Day 2, and follow-up.

Pulse rate

Timeframe: Screening, Day 1, Day 2, and follow-up.

ECG

Timeframe: Screening, Day 1, Day 2, and follow-up.

Echo

Timeframe: Screening day and follow-up

Clinical Laboratory data

Timeframe: Screening, Day 1, and follow-up.

Interventions:
  • Drug: GSK1120212
  • Drug: GSK1120212B
  • Enrollment:
    6
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Cathrine L. Denton, Carolyn Pendry, John Bauman, Graeme C. Young, May Ho, Frank Henriquez, Lei Fang, Royce A. Morrison, Keith Orford, Daniele Ouellet .Concomitant Oral and Intravenous Pharmacokinetics of Trametinib, a MEK Inhibitor, in Subjects With Solid Tumours.Br J Clin Pharmacol.2014;78(3):524–532
    Medical condition
    Cancer
    Product
    trametinib
    Collaborators
    Not applicable
    Study date(s)
    June 2011 to December 2011
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • 1. Male or female at least 18 years of age at the time of signing the informed consent form
    • 2. Histologically or cytologically confirmed diagnosis of a solid tumor that is not responsive to
    • 1. Currently receiving cancer therapy (e.g., chemotherapy with delayed toxicity, extensive
    • radiation therapy, immunotherapy, biologic therapy, or major surgery) within the last 3 weeks;

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Tacoma, Washington, United States, 98418
    Status
    Study Complete

    Study documents

    Clinical study report
    Available language(s): English
    Scientific result summary
    Available language(s): English

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    No longer a GSK study
    Actual primary completion date
    Not applicable
    Actual study completion date
    2011-17-12

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Participate in clinical trial
    Additional information
    Results for study 115064 can be found on the GSK Clinical Study Register.
    Click here
    Access to clinical trial data by researchers
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