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

Pulmonary Disease, Chronic Obstructive Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00500461
• Other study ID #: AC2106213
• Status: Completed
• Phase: Phase 1
• First received: July 10, 2007
• Last updated: August 3, 2017
• Start date: June 4, 2007
• Est. completion date: July 25, 2007

Study information

• Verified date: August 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: July 25, 2007
• Est. primary completion date: July 1, 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	London

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

This study has not been published in the scientific literature.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of GSK233705: lead II monitoring out to 8 hours post dose,		out to 8 hours post dose
Primary	measurement of heart rate, blood pressure and ECG, Holter monitoring and laboratory data out to 24 hours and		out to 24 hours
Primary	review of adverse events ongoing through out study.		through out study.
Secondary	Plasma and urine concentrations of GSK233705 and derived pharmacokinetic parameters, out to 48 hours post dose.		out to 48 hours post dose.

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
•   Results for study AC2106213 can be found on the GSK Clinical Study Register.