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A Healthy Volunteer Study With Inhaled GSK573719 and Placebo
This study has been completed.
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00803673
  Purpose

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


Condition Intervention Phase
Healthy Volunteer
Drug: 1000mcg
Drug: 100mcg
Drug: 500mcg
Drug: Placebo
Phase I

Drug Information available for: Magnesium Aluminum monostearate Calcium stearate n-Octadecanoic acid
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety Study
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 an

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Blood and urine levels of study drug [ Time Frame: various ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: May 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active 2: Experimental
500mcg '719
Drug: 500mcg
500mcg '719
Active: Experimental
100mcg 719
Drug: 100mcg
100mcg '719
Active 3: Experimental
1000mcg '719
Drug: 1000mcg
1000mcg '719
Placebo: Placebo Comparator
Placebo '719
Drug: Placebo
Placebo '719

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00803673

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

Responsible Party: GSK ( Study Director )
Study ID Numbers: 110106
Study First Received: December 4, 2008
Last Updated: December 4, 2008
ClinicalTrials.gov Identifier: NCT00803673  
Health Authority: Belgium: Institutional Review Board

Keywords provided by GlaxoSmithKline:
Healthy volunteers
New formulation

Study placed in the following topic categories:
Healthy

ClinicalTrials.gov processed this record on January 16, 2009