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A Healthy Volunteer Study With Inhaled GSK573719 and Placebo

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00803673
Recruitment Status : Completed
First Posted : December 5, 2008
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: 100mcg Drug: 500mcg Drug: 1000mcg Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.
Actual Study Start Date : May 5, 2008
Actual Primary Completion Date : October 16, 2008
Actual Study Completion Date : October 16, 2008

Arm Intervention/treatment
Experimental: Active
100mcg 719
Drug: 100mcg
100mcg '719

Experimental: Active 2
500mcg '719
Drug: 500mcg
500mcg '719

Experimental: Active 3
1000mcg '719
Drug: 1000mcg
1000mcg '719

Placebo Comparator: Placebo
Placebo '719
Drug: Placebo
Placebo '719




Primary Outcome Measures :
  1. General safety and tolerability endpoints: Adverse Events (AE), HR, BP, 12- lead ECG and lung function (FEV1) and clinical laboratory safety tests [ Time Frame: Various ]

Secondary Outcome Measures :
  1. Blood and urine levels of study drug [ Time Frame: various ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00803673


Locations
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Belgium
GSK Investigational Site
Antwerpen, Belgium, 2060
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Study Data/Documents: Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 110106
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 110106
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 110106
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 110106
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 110106
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 110106
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 110106
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00803673     History of Changes
Other Study ID Numbers: 110106
First Posted: December 5, 2008    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
Healthy volunteers
New formulation

Additional relevant MeSH terms:
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Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive