Last updated: 11/04/2018 04:29:09

Effect of GSK704838 In Healthy Volunteers

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GSK study ID
AC6108697
See study documents
Clinicaltrials.gov ID
NCT00539825
EudraCT ID
2007-003202-10
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A randomized double-blind, placebo-controlled, crossover, dose escalation study to examine the safety, tolerability, pharmacodynamics and pharmacokinetics of single inhaled doses of GSK704838 and tiotropium bromide
Trial description: GSK704838C is a potent, pan-active mAChR antagonist, which is being developed for
once-daily treatment of chronic obstructive pulmonary disease (COPD).
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: GSK704838
Enrollment:
20
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
GSK704838
Collaborators
Not applicable
Study date(s)
September 2007 to February 2008
Type
Interventional
Phase
1

Participation criteria

Sex
Male
Age
18 - 55 years
Accepts healthy volunteers
Yes
  • Healthy male subject
  • Aged between 18-55 years inclusive.
  • Any clinically relevant and important abnormality identified at the screening medical
  • assessment (physical examination/medical history), clinical laboratory tests, or ECG
Inclusion and exclusion criteria
Inclusion criteria:
  • Healthy male subject
  • Aged between 18-55 years inclusive.
  • Non-smokers
  • Normal spirometry
  • A signed and dated written informed consent is obtained from the subject.
  • The subject is capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  • Available to complete the study.
  • The subject is =50kg with a body mass index within the range 19.0 to 29.9 kg/m2 inclusive.
  • Response to ipratropium bromide
Exclusion criteria:
  • Any clinically relevant and important abnormality identified at the screening medical assessment (physical examination/medical history), clinical laboratory tests, or ECG (12-lead or Holter).
  • A history of breathing problems
  • A mean QTc(B) value > 450ms, the QTc(B) of the 3 screening ECGs are not within 10% of the mean, a PR interval outside the range 90-210ms or an ECG that is not suitable for QT measurements at screening.
  • A history of elevated resting blood pressure or a mean blood pressure higher than 140/90 mmHg at screening.
  • A mean heart rate outside the range 40-90 bpm inclusive at screening.
  • History of use of tobacco- or nicotine-containing products within 6 months of screening, and/or positive urine cotinine test results at screening.
  • Where participation in the study would result in donation of blood in excess of 500mL within a 56 day period at screening.

    • The subject is currently taking regular (or a course of) medication, whether prescribed or not, including herbal remedies such as St John's Wort etc. The subject has taken:

    • prescription medications for 14 days prior to first dose of study drug, or
    • Over-the-counter (OTC) medications/preparations (including herbal remedies, etc.) excluding simple analgesics for 48 hours prior to first dose of study drug, unless it is judged by the Investigator not to compromise the subject's safety or influence the outcome of the study.
  • The subject has participated in a study with a new molecular entity or any other trial within a period of 3 months prior first dose of study drug.
  • The subject has tested positive for hepatitis C antibody (third generation enzyme immunoassay), hepatitis B surface antigen or HIV antibodies (if tested according to site SOP's) at screening.
  • The subject has tested positive for drugs-of-abuse at screening.
  • The subject has tested positive for urine alcohol (including ethanol) at screening. The detection of alcohol would not be an exclusion at screening but would need to be negative pre-dose and during the study.
  • The subject is unable to use the DISKUS™ and/or HandiHaler inhaler devices correctly at screening.
  • The subject has a suspected history of alcohol abuse within the six months previous to the screening visit.
  • The subject has a known allergy or hypersensitivity to magnesium stearate, milk protein or the excipient lactose monohydrate, iodine, ipratropium bromide, tiotropium bromide, atropine and/or any of its derivatives.
  • The subject has a significant clinical history of prostatic hypertrophy or narrow angle glaucoma.
  • The subject has received an allogeneic bone marrow transplant.
  • The subject has claustrophobia that may be aggravated by entering the whole body plethysmography cabinet.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Harrow, Middlesex, United Kingdom, HA1 3UJ
Status
Will Be Recruiting
Contact us

Study documents

Clinical study report
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
Completed
Actual primary completion date
Not applicable
Actual study completion date
2008-02-02

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

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