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

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00500461

Collaborator

(none)

Enrollment

Location

Arm

1.7

Actual Duration (Months)

5.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Disease, Chronic Obstructive	Drug: GSK233705	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

9 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Jun 4, 2007

Actual Primary Completion Date :

Jul 1, 2007

Actual Study Completion Date :

Jul 25, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Subjects receiving GSK233705 Each subject will receive one or more ascending doses given as a constant rate IV infusion over 30 minutes and a single oral dose of 250 microgram GSK233705 solution. IV doses will include 30, 70, 110 microgram of GSK233705 at specified time points.	Drug: GSK233705 GSK233705 will be available as IV infusion and oral solution containing Cellobiose octaacetate.

Arm

Intervention/Treatment

Experimental: Subjects receiving GSK233705

Each subject will receive one or more ascending doses given as a constant rate IV infusion over 30 minutes and a single oral dose of 250 microgram GSK233705 solution. IV doses will include 30, 70, 110 microgram of GSK233705 at specified time points.

Drug: GSK233705

GSK233705 will be available as IV infusion and oral solution containing Cellobiose octaacetate.

Outcome Measures

Primary Outcome Measures

Safety and tolerability of GSK233705: lead II monitoring out to 8 hours post dose, [out to 8 hours post dose]
measurement of heart rate, blood pressure and ECG, Holter monitoring and laboratory data out to 24 hours and [out to 24 hours]
review of adverse events ongoing through out study. [through out study.]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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