Last updated: 11/04/2018 04:25:48

Study To Examine Safety, Tolerability And Pharmacokinetics Of Intravenous Doses And Oral Dose Of GSK233705

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GSK study ID
AC2106213
See study documents
Clinicaltrials.gov ID
NCT00500461
EudraCT ID
2006-006081-42
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, open-label, sequential ascending cross over study to examine safety, tolerability, pharmacodynamics and pharmacokinetics of ascending single doses, nominally 10, 30, 70 and 110µg intravenous doses and a single 250µg oral dose of GSK233705 in healthy volunteers.
Trial description: GSK233705 is being developed for the treatment of chronic obstructive pulmonary disease. This will be an open-label, dose-ascending study in 7 healthy male subjects to establish well tolerated intravenous doses and an oral dose of GSK233705. The main objective of the study is to confirm an IV and oral dose for a definitive human radiolabel metabolic study.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Safety and tolerability of GSK233705: lead II monitoring out to 8 hours post dose,

Timeframe: out to 8 hours post dose

measurement of heart rate, blood pressure and ECG, Holter monitoring and laboratory data out to 24 hours and

Timeframe: out to 24 hours

review of adverse events ongoing through out study.

Timeframe: through out study.

Secondary outcomes:

Plasma and urine concentrations of GSK233705 and derived pharmacokinetic parameters, out to 48 hours post dose.

Timeframe: out to 48 hours post dose.

Interventions:
Drug: GSK233705
Enrollment:
9
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)
June 2007 to July 2007
Type
Interventional
Phase
1

Participation criteria

Sex
Male
Age
25 - 55 years
Accepts healthy volunteers
Yes
  • Healthy male subjects;
  • Between the ages of 18-55 years, inclusive
  • Any clinically important abnormality identified in the following: at the screening medical assessment
  • A mean QTc(B) value at screening >450msec, the QTc(B) of the 3 screening ECGs are not within 10% of the mean, a PR interval outside the range 90-210msec or an ECG that is not suitable for QT measurements
Inclusion and exclusion criteria
Inclusion criteria:
  • Healthy male subjects;
  • Between the ages of 18-55 years, inclusive
  • Body mass index within the range 18.0 to 30.0 kg/m2.
  • Non-smokers
  • Adequate venous access for intermittent cannulation
  • A signed and dated written informed consent is obtained from the subject
  • The subject is capable of giving informed consent
  • Available to complete the study
Exclusion criteria:
  • Any clinically important abnormality identified in the following: at the screening medical assessment
  • A mean QTc(B) value at screening >450msec, the QTc(B) of the 3 screening ECGs are not within 10% of the mean, a PR interval outside the range 90-210msec or an ECG that is not suitable for QT measurements
  • 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 of 40-90 bpm at screening.
  • History of use of tobacco- or nicotine-containing products within 6 months of screening or a positive cotinine test at screening.
  • The subject has donated a unit (400ml) of blood within 60 days of screening, or, intends to donate during the study.
  • The subject is currently taking regular (or course of) medication, whether prescribed or not, including herbal remedies such as St John’s Wort.
  • The subject has taken: prescription medications within the past 2 weeks prior to dosing, or OTC medications (except simple analgesics) within 48 hours prior to dosing, unless it is judged by the Investigator not to compromise their safety or influence the outcome of the study.
  • The subject has participated in a study with a new molecular entity within a period of 3 months prior to dosing.
  • The subject has tested positive for hepatitis C antibody, hepatitis B surface antigen or HIV

Trial location(s)

Location
Status
Contact us
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Location
GSK Investigational Site
London, United Kingdom, NW10 7NS
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
2007-25-07

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
Results for study AC2106213 can be found on the GSK Clinical Study Register.
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