Last updated: 11/04/2018 10:16:19

A Study Investigating Blood Concentrations Of Rosuvastatin When Co-administered With GW856553 In Healthy Men

GSK study ID
PM1106502
Clinicaltrials.gov ID
EudraCT ID
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 randomized, single blind, repeat dose, placebo-controlled, single-period, parallel group study to investigate the safety, tolerability and potential pharmacokinetic interactions between GW856553 and Rosuvastatin (10mg), when co-administered in healthy adult male subjects
Trial description: This study is being conducted to provide initial safety and tolerability data as well as to provide PK data on potential interactions when GW856553 and rosuvastatin are co-administered in healthy male adults
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:

PK blood draws at days 14 and 28

Timeframe: days 14 and 28

Secondary outcomes:

The primary pharmacokinetic endpoints of interest are AUC(0-τ) and Cmax for rosuvastatin

Timeframe: days 14, 15, 28

The secondary pharmacokinetic endpoints of interest are Tmax and t1/2 for rosuvastatin

Timeframe: days 14, 15, 28

Measurement of alanine aminotransferase (ALT) and maximum change from baseline in ALT in all subjects

Timeframe: days -1, 13, 14, 16, 18, 20, 22, 24, 26, 28, follow up

Clinical safety data from spontaneous adverse event reporting, 12-lead ECG recording, vital sign measurement, nursing/physician observation and safety laboratory examination.

Timeframe: days -1, 13, 14, 16, 22, 26, 28, follow up

Analysis of LPS induction of IL-1b, IL-6, IL-8 and TNFa, as well as additional biomarkers, as data permit.

Timeframe: day 1, 14, 21, 28

Interventions:
  • Drug: GW856553
  • Enrollment:
    44
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Atherosclerosis, Cardiovascular Disease
    Product
    losmapimod
    Collaborators
    Not applicable
    Study date(s)
    October 2007 to December 2007
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Male
    Age
    18 - 55 years
    Accepts healthy volunteers
    Yes
    • Inclusion criteria:
    • Healthy adult males, 18-55 years of age, inclusive

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Dallas, Texas, United States, 75247
    Status
    Study Complete

    Study documents

    Clinical study report
    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
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2007-04-12

    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

    Additional information
    Not applicable
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