A Healthy Volunteer Study With Inhaled GSK573719 and Placebo

NCT00803673 | Completed Phase 1

• 1 other identifier: 110106
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Keywords

Healthy volunteers; New formulation

Outcome Measures

Primary Outcomes (1)

• General safety and tolerability endpoints: Adverse Events (AE), HR, BP, 12- lead ECG and lung function (FEV1) and clinical laboratory safety tests

  Various

Secondary Outcomes (1)

• Blood and urine levels of study drug

  various

Study Arms (4)

Active

EXPERIMENTAL

100mcg 719

Drug: 100mcg

Active 2

EXPERIMENTAL

500mcg '719

Drug: 500mcg

Active 3

EXPERIMENTAL

1000mcg '719

Drug: 1000mcg

Placebo

PLACEBO COMPARATOR

Placebo '719

Drug: Placebo

Interventions

100mcg DRUG

100mcg '719

Active

500mcg DRUG

500mcg '719

Active 2

1000mcg DRUG

1000mcg '719

Active 3

Placebo DRUG

Placebo '719

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Antwerp, 2060, Belgium

Location

Related Publications (1)

• 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.

  PMID: 23881566 DERIVED

Related Links

• Results for study 110106 can be found on the GSK Clinical Study Register.
• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2008
• First Posted: December 5, 2008
• Study Start: May 5, 2008
• Primary Completion: October 16, 2008
• Study Completion: October 16, 2008
• Last Updated: July 21, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)