Last updated: 11/04/2018 06:01:40

To estimate relative bioavailability of 5 formulations of ronacaleret given to healthy postmenopausal females

GSK study ID
CR9106341
Clinicaltrials.gov ID
NCT00651534
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: An open-label, randomized, five period crossover study to estimate the relative bioavailability of five formulations of 400 mg ronacaleret (a calcium-sensing receptor antagonist) administered as a single oral dose to healthy postmenopausal females.
Trial description: This study will examine the effects of formulation on the relative bioavailability of SB-751689 (400 mg) administered to healthy postmenopausal women. Subjects will receive a single oral dose of each formulation, with five formulations of SB-751689 tested in total. Blood samples will be taken up to 24 hours postdose after each dose administration. This study will provide information for future possible formulation development of SB-751689 for Phase III.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: Ronacaleret
    • Enrollment:
    32
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Osteoporosis
    Product
    ronacaleret
    Collaborators
    Not applicable
    Study date(s)
    February 2008 to April 2008
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female
    Age
    Not applicable
    Accepts healthy volunteers
    Yes
    • Inclusion criteria:
    • Healthy postmenopausal women
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Healthy postmenopausal women
    • Non-smokers
    • Body weight > or = 50 kg and BMI within the range 19-32 kg/m2
    • Capable of giving written informed consent and complying with the requirements and restrictions listed in the consent form
    • QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block
    • Hispanic or non-Hispanic (Caucasian) ethnicity Exclusion criteria:
    • Any clinically relevant biological or physical abnormality found or reported at screening which, in the opinion of the investigator, is clinically significant and would preclude safe participation in this study
    • Positive urine drug screen at screening
    • Positive urine test for alcohol at pre-dose
    • Positive for HIV or hepatitis B or C virus at screening
    • Urinary cotinine levels indicative of smoking at screening
    • History of smoking or use of nicotine containing products within one year of the study or >10 pack-year history of smoking overall
    • History of regular alcohol consumption exceeding 7 units/week (1 unit = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening
    • History of drug abuse within 6 months of the study
    • Participation in a clinical study and received a drug or a new chemical entity with 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of the current study medication.
    • Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
    • Use of prescription or non-prescription drugs
    • Consumption of red wine, grapefruit, grapefruit juice or grapefruit containing products within 14 days prior to the first dose of study medication
    • Donation of blood in excess of 500 mL within 56 days prior to dosing
    • Evidence of renal, hepatic or biliary impairment
    • History of serious gastrointestinal disease
    • History of sensitivity to any of the study medications or components thereof or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation.
    • History of clinically significant cardiovascular disease
    • Medical conditions that might alter bone metabolism
    • Serum parathyroid hormone (iPTH) test levels outside the reference range at screening
    • Liver function tests, parathyroid hormone test or CPK outside the reference range at screening

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Port Orange, Florida, United States, 32127
    Status
    Study Complete
    Contact us

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2008-06-04

    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

    Additional information
    Not applicable
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