A Healthy Volunteer Study With Inhaled GSK573719 and Placebo

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

A Single Centre, Randomized, Double-blind, Dose Ascending, Placebo-controlled Study, in Two Parts, to Evaluate the Safety, Tolerability and Pharmacokinetics of Escalating Single and Repeat Inhaled Doses of GSK573719 and Placebo Formulated With the Excipient Magnesium Stearate, in Healthy Subjects and in a Healthy Population of Cytochrome P450 Isoenzyme 2D6 Poor Metabolisers.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00803673
• Other study ID #: 110106
• Status: Completed
• Phase: Phase 1
• First received: December 4, 2008
• Last updated: July 18, 2017
• Start date: May 5, 2008
• Est. completion date: October 16, 2008

Study information

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

Clinical Trial Summary

This study is to look at a new formulation of GSK573719 to see if it is safe and tolerated in healthy volunteers

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 16, 2008
• Est. primary completion date: October 16, 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy.

• Male or female 18 to 65 years of age inclusive.

• Non-childbearing women or women of child bearing potential who agree to use contraception

• Subject has had their CYP2D6 genotype confirmed and can be included in either of the following parts:

• Part 1: may include extensive, intermediate and ultra-rapid metabolizers

• Part 2: includes only poor (no enzyme activity) metabolizers, with previously confirmed phenotype

• Body Mass Index within the range 18 - 30 kg/m2 (inclusive).

• Capable of giving written informed consent

• Normal ECG;

• Normal lung function.

• Non-smokers (never smoked or not smoking for >6 months with <10 pack years history (Pack years = (cigarettes per day smoked/20) x number of years smoked))

• 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 at the screening medical assessment (physical examination/medical history), clinical laboratory tests, or ECG (12-lead). 24hr Holter monitoring outside normal limits.

• A history of breathing problems (i.e. history of asthmatic symptomatology).

• Abnormal ECG.

• Abnormal blood pressure.

• Abnormal heart rate

• The subject has a positive pre-study drug/alcohol screen.

• A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within three months of screening.

• A positive test for HIV antibody (if determined by the local SOPs).

• History of high alcohol consumption within three months of the study

• The subject has participated in a clinical trial and has received an IP within the following time period prior to the first dosing day in the current study: 30 days, five half-lives or twice the duration of the biological effect of the IP (whichever is longer).

• Exposure to more than four new chemical entities within 12 months prior to the first dosing day.

• Use of prescription or non-prescription drugs, (except for simple analgesics e.g. paracetamol), including vitamins, herbal and dietary supplements (including St John's Wort) within seven days (or 14 days if the drug is a potential enzyme inducer) or five half-lives (whichever is longer) prior to the first dose of study medication

• History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.

• Where participation in the study would result in donation of blood or blood products in excess of 500mL within a 56 day period.

• Unwillingness or inability to follow the procedures outlined in the protocol.

• Urinary cotinine levels indicative of smoking or history of regular use of tobacco- or nicotine-containing products prior to screening.

• The subject is unable to use the novel dry powder inhaler correctly.

• The subject has a known allergy or hypersensitivity to milk protein or the excipients magnesium stearate and lactose monohydrate.

Related Conditions & MeSH terms

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

Intervention

Drug:
• 100mcg
100mcg '719
• 500mcg
500mcg '719
• 1000mcg
1000mcg '719
• Placebo
Placebo '719

Locations

Country	Name	City	State
Belgium	GSK Investigational Site	Antwerpen

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	General safety and tolerability endpoints: Adverse Events (AE), HR, BP, 12- lead ECG and lung function (FEV1) and clinical laboratory safety tests		Various
Secondary	Blood and urine levels of study drug		various

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 110106 can be found on the GSK Clinical Study Register.