Last updated: 11/04/2018 11:31:18

Study To Determine The Effects Of Doses Of Relacatib On The Metabolism Of Acetaminophen, Ibuprofen And Atorvastatin

GSK study ID
SB-462795/008
See study documents
Clinicaltrials.gov ID
NCT00411190
EudraCT ID
2006-004491-12
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 study to evaluate the potential for pharmacokinetic interaction between SB 462795 and SSRIs in healthy subjects [3A]
Trial description: Relacatib is being developed for the treatment of osteoporosis, osteoarthritis and possibly other bone disorders. Recent results suggest that relacatib interacts with the way our bodies metabolise drugs and so some drugs which are commonly prescribed to the intended target patient population could be affected by giving relacatib at the same time. The purpose of this study is to evaluate the effect of repeat dose administration of relacatib on the way subjects bodies metabolise three commonly prescribed medications in the osteoarthritis population: ibuprofen, acetaminophen, and atorvastatin.
Primary purpose:
Diagnostic
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

The primary objective of this study is to characterize the effect of relacatib at steady-state on the pharmacokinetics of a single oral dose of acetaminophen, ibuprofen and atorvastatin in healthy postmenopausal females.

Timeframe: Up to Day 17

Secondary outcomes:

To assess the safety and tolerability of the concomitant administration of oral doses of relacatib and acetaminophen, ibuprofen and atorvastatin. To describe the changes from baseline in serum CTXI levels for each relacatib dose tested.

Timeframe: Up to Day 17

Interventions:
  • Drug: Relacatib
  • Drug: Acetaminophen
  • Drug: Ibuprofen
  • Drug: Atorvastatin
    • Enrollment:
    32
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Osteoarthritis
    Product
    relacatib
    Collaborators
    Not applicable
    Study date(s)
    October 2006 to December 2006
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female
    Age
    18 - 70 years
    Accepts healthy volunteers
    Yes
    • Healthy
    • Postmenopausal
    • Subjects with known morphea or sclerodermia
    • Subjects with a history of myocardial infarction.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Healthy
    • Postmenopausal
    • Body weight > 50 kg
    • Body mass index (BMI) between 19 and 30
    • The subject is willing and able to give a signed and dated written informed consent prior to admission to the study
    • The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
    Exclusion criteria:
    • Subjects with known morphea or sclerodermia
    • Subjects with a history of myocardial infarction.
    • Subjects with a history of renal/or hepatic disease unless the disease has been successfully treated and is no longer active; subjects with any evidence of renal/ or hepatic impairment on the screening physical and laboratory examination.
    • Subjects with history of hypertension or systolic blood pressure
    • Subjects with history of diabetes
    • History of regular alcohol consumption exceeding 7 drinks/week (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening.
    • History of use of tobacco- or nicotine-containing products within 6 months of screening, or a positive urine cotinine indicative of smoking at screening.
    • Positive urine drug screen including alcohol (or alcohol breath test) at screening.
    • Positive for HIV, hepatitis B virus or hepatitis C virus.
    • Donation of blood in excess of 500 mL within 56 days prior to dosing
    • History of sensitivity or contraindications to any of the study medications (i.e., relacatib, paracetamol, ibuprofen or atorvastatin) or components thereof.
    • Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
    • Subjects whom are judged by the investigator to be at risk for acute angle closure glaucoma.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Antwerpen, Belgium, 2060
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Liège, Belgium, 4000
    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
    2006-15-12

    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 SB-462795/008 can be found on the GSK Clinical Study Register.
    Click here
    Access to clinical trial data by researchers
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