Last updated: 11/04/2018 11:57:08

The safety and tolerability of GW805858 in healthy volunteers and mild asthmatics

GSK study ID
SF2105450
See study documents
Clinicaltrials.gov ID
NCT00453791
EudraCT ID
2005-005331-10
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A randomised, single and repeat dose, double-blind, placebo controlled study to assess the safety and tolerability of GW805858 in healthy volunteers and mild asthmatics
Trial description: This study will be the First Time in Human Study (FTIH) aiming to assess the safety and tolerability of GW805858 for both single and repeat dose. The study also
aims to assess safety and tolerability in mild asthmatic subjects as well as healthy
volunteers.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Safety and tolerability parameters will be compared between active and placebo treatment groups using summary statistics. No formal statistical analyses of the safety and tolerability data will be performed.

Timeframe: Up to 18 weeks

Secondary outcomes:

Derived GW805858 and GW288967 PK parameters will be compared between active and placebo treatment groups using summary statistics.

Timeframe: Pre-dose, 5,20,30,45,60,90 minutes, 2,3,4,6,8,10,12,12.5,13,14, 24 hours Post-dose on Days 1 and 28.

Interventions:
  • Drug: GW805858
  • Drug: Placebo
    • Enrollment:
    31
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Asthma
    Product
    GW805858
    Collaborators
    Not applicable
    Study date(s)
    February 2006 to April 2006
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 60 years
    Accepts healthy volunteers
    Yes
    • Men or women of non-child bearing potential, aged between 18 and 60 years of age inclusive.
    • Body weight = 50 kg (110 lbs) for men and = 45 kg for women and Body Mass Index (BMI) within the range 19.0-30.0 kg/m2 inclusive.
    • The subject has a history of allergy to ingredients within the inhaler.
    • The subject has received an investigational drug or participated in any other research trial within 30 days, prior to the first dose of current study medication.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Men or women of non-child bearing potential, aged between 18 and 60 years of age inclusive.
    • Body weight = 50 kg (110 lbs) for men and = 45 kg for women and Body Mass Index (BMI) within the range 19.0-30.0 kg/m2 inclusive.
    • The subject is a current non-smoker who has not used any tobacco products in the last year.
    • A signed and dated written informed consent is obtained for the subject.
    • The subject is able to understand and comply with protocol requirements and timetables, instructions and protocol-stated restrictions.
    • If asthmatic, the subject must be a clinically stable asthmatic.
    Exclusion criteria:
    • The subject has a history of allergy to ingredients within the inhaler.
    • The subject has received an investigational drug or participated in any other research trial within 30 days, prior to the first dose of current study medication.
    • The subject has used prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 14 days prior to the first dose of study medication.
    • The subject has an average weekly alcohol intake of greater than 21 units if male or 14 units if female.
    • The subject has any history of breathing problems (e.g. history of asthmatic symptoms).
    • The subject is infected with the hepatitis B, hepatitis C, or HIV virus.
    • The subject has had a respiratory tract infection or worsening of asthma within 4 weeks of the start of the study.
    • The subject has a past or present disease, which as judged by the Investigator, may affect the outcome of this study.
    • The subject has a history of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxia seizures.
    • The subject has taken inhaled, nasal or dermal steroids within 4 weeks or oral steroids within 8 weeks of the start of the study.
    • The subject is unable to abstain from other drugs that may interfere with the conduct of the study.
    • The subject has ongoing rhinitis that requires treatment.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    London, United Kingdom, SW20 0NE
    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
    Other
    Actual primary completion date
    Not applicable
    Actual study completion date
    2006-10-04

    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

    Participate in clinical trial
    Additional information
    Results for study SF2105450 can be found on the GSK Clinical Study Register.
    Click here
    Access to clinical trial data by researchers
    Visit website