Last updated: 11/07/2018 01:04:52
A randomized double-blind, placebo-controlled, crossover, dose escalation study to examine the safety, tolerability, pharmacodynamics and pharmacokinetics of inhaled doses of GSK233719 in healthy normal volunteers (single and repeat dosing) and in healthy CYP2D6 poor metaboliser volunteers (single or repeat dosing).
Clinicaltrials.gov ID
Not applicable
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A randomized double-blind, placebo-controlled, crossover, dose escalation study to examine the safety, tolerability, pharmacodynamics and pharmacokinetics of inhaled doses of GSK233719 in healthy normal volunteers (single and repeat dosing) and in healthy CYP2D6 poor metaboliser volunteers (single or repeat dosing).
Trial description: A randomized double-blind, placebo-controlled, crossover, dose escalation study to examine the safety, tolerability, pharmacodynamics and pharmacokinetics of inhaled doses of GSK233719 in healthy normal volunteers (single and repeat dosing) and in healthy CYP2D6 poor metaboliser volunteers (single or repeat dosing).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Cahn A, Tal-Singer R, Pouliquen IJ, Mehta R, Preece A, Hardes K, Crater G, Deans A. Safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat inhaled doses of umeclidinium in healthy subjects: two randomized studies. Clin Drug Invest. 2013;33(7):477.
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
umeclidinium bromide
Collaborators
Not applicable
Study date(s)
July 2006 to October 2006
Type
Not applicable
Phase
1
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2006-05-10
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
Not applicable
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