A Healthy Volunteer Study With Inhaled GSK573719 and Placebo

NCT ID: NCT00803673

Last Updated: 2017-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-05
• Study Completion Date: 2008-10-16

Brief Summary

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

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active

100mcg 719

Group Type: EXPERIMENTAL

100mcg

Intervention Type: DRUG

100mcg '719

Active 2

500mcg '719

Group Type: EXPERIMENTAL

500mcg

Intervention Type: DRUG

500mcg '719

Active 3

1000mcg '719

Group Type: EXPERIMENTAL

1000mcg

Intervention Type: DRUG

1000mcg '719

Placebo

Placebo '719

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo '719

Interventions

100mcg

100mcg '719

Intervention Type: DRUG

500mcg

500mcg '719

Intervention Type: DRUG

1000mcg

1000mcg '719

Intervention Type: DRUG

Placebo

Placebo '719

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Antwerp, , Belgium

Countries

Belgium

References

Cahn A, Mehta R, Preece A, Blowers J, Donald A. Safety, tolerability and pharmacokinetics and pharmacodynamics of inhaled once-daily umeclidinium in healthy adults deficient in CYP2D6 activity: a double-blind, randomized clinical trial. Clin Drug Investig. 2013 Sep;33(9):653-64. doi: 10.1007/s40261-013-0109-6.

Reference Type: DERIVED

PMID: 23881566 (View on PubMed)

Study Documents

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

110106

Identifier Type: -

Identifier Source: org_study_id