Clinical trial NCT00500461: Study To Examine Safety, Tolerability And Pharmacokinetics Of Intravenous Doses And Oral Dose Of GSK233705
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Muscarinic Receptor Antagonist,
intravenous infusion,
pharmacokinetics
healthy subjects,
safety,
tolerability,
Anticholinergic,
oral dosing,
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-07-12
Enrollment: 9
Sex: MALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Safety and tolerability of GSK233705: lead II monitoring out to 8 hours post dose,
timeFrame: out to 8 hours post dose
measure: measurement of heart rate, blood pressure and ECG, Holter monitoring and laboratory data out to 24 hours and
timeFrame: out to 24 hours
measure: review of adverse events ongoing through out study.
timeFrame: through out study.
Secondary outcomes:
measure: Plasma and urine concentrations of GSK233705 and derived pharmacokinetic parameters, out to 48 hours post dose.
timeFrame: out to 48 hours post dose.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: This study has not been published in the scientific literature.