Last updated: 11/07/2018 08:27:17

First time in human study using GSK2330672

Request patient level data
GSK study ID
114985
See study documents
Clinicaltrials.gov ID
NCT01416324
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A first time in human, single blind, randomized, placebo-controlled,dose escalating crossover study to evaluate the safety,tolerability, pharmacokinetic and pharmacodynamic parameters of single doses of GSK2330672 in healthy volunteers
Trial description: The purpose of this study is to look at the safety and tolerability of increasing single doses of GSK2330672 in healthy volunteers.
Primary purpose:
Basic Science
Trial design:
Crossover Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:

Change in vital signs

Timeframe: 1, 2, 4, 8, 12, 24, 48 hours

ECGs relative to placebo

Timeframe: 1, 2, 4, 8, 12, 24, 48 hours

Changes in clinical lab results

Timeframe: 24 hours

lung function tests

Timeframe: 1, 3, 8, 24 hours

Adverse events relative to placebo

Timeframe: 48 hour monitoring

Secondary outcomes:

Measurement of the maximum concentration (Cmax) for study drug

Timeframe: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3.5, 5, 6.5, 8, 9.5, 12.5 hours

Measurement of the time to achieve maximum concentration (tmax) for study drug

Timeframe: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3.5, 5, 6.5, 8, 9.5, 12.5 hours

Measurement of area under the curve (AUC) for study drug

Timeframe: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3.5, 5, 6.5, 8, 9.5, 12.5 hours

Measurement of half life (t 1/2) of study drug

Timeframe: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3.5, 5, 6.5, 8, 9.5, 12.5 hours

Measurement of apparent clearance (CL/F) of the study drug

Timeframe: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3.5, 5, 6.5, 8, 9.5, 12.5 hours

Measurement of the apparent volume of distribution (V/F) of the study drug

Timeframe: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3.5, 5, 6.5, 8, 9.5, 12.5 hours

Interventions:
  • Drug: placebo
  • Drug: 0.1 mg GSK2330672
  • Drug: 0.3 mg GSK2330672
  • Drug: 1 mg GSK2330672
  • Drug: 3 mg GSK2330672
  • Drug: 10 mg GSK2330672
  • Drug: 30 mg GSK2330672
  • Drug: 60 mg GSK2330672
    • Enrollment:
    17
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Diabetes Mellitus, Type 2
    Product
    GSK2330672
    Collaborators
    Not applicable
    Study date(s)
    June 2011 to September 2011
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 60 years
    Accepts healthy volunteers
    Yes
    • healthy volunteer
    • 18-60 yrs of age
    • pregnant or breastfeeding females
    • positive HIV
    Inclusion and exclusion criteria
    Inclusion criteria:
    • healthy volunteer
    • 18-60 yrs of age -for subjects age 50 and above: negative fecal occult blood test within 3 months prior to expected start of dosing, and normal results from sigmoidoscopy or colonoscopy within 5 yrs prior to dosing.
    • if female, must be of non-childbearing potential
    Exclusion criteria:
    • pregnant or breastfeeding females
    • positive HIV -positive Hep B, or Hep C within 3 months of screening -positive drugs of abuse screening
    • triglycerides > 250 mg/dL
    • current or chronic history of liver disease -any gastrointestinal or gastrointestinal related conditions that could affect fat or bile acid reabsorption -pancreatitis
    • colon cancer or 1st degree relative who has had colon cancer -abnormal lung function tests -inability to perform lung function tests -unwilling to abstain from smoking, alcohol, caffeine, illicit drugs as directed by the site staff -exposure to more than 4 new chemical entities in the 12 months prior to the first dosing day. -where participation in the study would results in donation of more than approximately 550mL of blood in a 56-day period.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Minneapolis, Minnesota, United States, 55404
    Status
    Study Complete
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

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

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2011-09-09

    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 114985 can be found on the GSK Clinical Study Register.
    Click here
    Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
    Click here
    Access to clinical trial data by researchers
    Visit website