Last updated: 11/04/2018 04:27:09

A Single Centre Randomized Study Evaluating The Safety And Tolerability Of GSK233705 In Healthy Volunteers.

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GSK study ID
AC2108380
See study documents
Clinicaltrials.gov ID
NCT00453687
EudraCT ID
Not applicable
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 single-centre, randomized, double-blind placebo-controlled, dose-ascending, cross-over study to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of single inhaled doses of GSK233705, formulated with the excipient magnesium stearate, in healthy volunteers
Trial description: This study will investigate the safety and tolerability of inhaled doses of GSK233705 with a new formulation.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

General safety and tolerability endpoints: adverse events, blood pressure, heart rate, 12-lead electrocardiogram (ECG), Holter and Lead II ECG monitoring, lung function (FEV1, FVC) and clinical laboratory safety tests over 24 hours.

Timeframe: over 24 hours.

Secondary outcomes:

Plasma and urine concentrations of GSK233705 and derived pharmacokinetic parameters from 0 to 24 hours. Serial Specific airway conductance (sGaw) and Forced Expiratory Volume in 1 second (FEV1) measurements over 24 hours post-dose.

Timeframe: over 24 hours

Interventions:
Drug: GSK233705
Enrollment:
12
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
This study has not been published in the scientific literature.
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
darotropium bromide
Collaborators
Not applicable
Study date(s)
March 2007 to May 2007
Type
Interventional
Phase
1

Participation criteria

Sex
Male
Age
18 - 55 years
Accepts healthy volunteers
Yes
  • Healthy male subjects 18-55 years old
  • Non-Smokers
  • Any subject with breathing problems.
  • High blood pressure and heart abnormalities.
Inclusion and exclusion criteria
Inclusion criteria:
  • Healthy male subjects 18-55 years old
  • Non-Smokers
Exclusion criteria:
  • Any subject with breathing problems.
  • High blood pressure and heart abnormalities.
  • Any subjects currently taking prescription and non-prescription medications.

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Baltimore, Maryland, United States, 21225
Status
Study Complete
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Study documents

Clinical study report
Available language(s): English
Download document(s)
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
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-16-05

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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Additional information
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