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A Study of GSK573719 in Healthy Japanese Male Subjects

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ClinicalTrials.gov Identifier: NCT01013974
Recruitment Status : Completed
First Posted : November 16, 2009
Last Update Posted : August 3, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is a single centre, randomized, double blind, placebo controlled, single and repeat dose study to investigate the safety, tolerability, and pharmacokinetics of inhaled dose of GSK573719 with lactose and containing magnesium stearate by a novel dry powder device in healthy Japanese male subjects.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: GSK573719 250 μg Drug: GSK573719 500 μg Drug: GSK573719 1000 μg Drug: GSK573719 matching Placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Phase I Study of GSK573719 -A Randomized, Double Blind, Placebo Controlled, Dose Ascending, Single and Repeat Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Inhaled Dose of GSK573719 From a Novel Dry Powder Device in Healthy Japanese Male Subjects
Actual Study Start Date : October 5, 2009
Primary Completion Date : December 18, 2009
Study Completion Date : December 18, 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: GSK573719 250 microgram (μg) arm
Each subject will receive the first dose of GSK573719 250 μg on Day 1 followed by once daily dosing for 7 days from Day 4 to Day 10 via a novel dry powder inhaler.
Drug: GSK573719 250 μg
Strip 1 of the dry powder inhaler will contain GSK573719 250 μg micronized drug with lactose along with magnesium stearate. Strip 2 will contain lactose powder along with magnesium stearate. It will be available as dry off white powder for inhalation.
Experimental: GSK573719 500 μg arm
Each subject will receive the first dose of GSK573719 500 μg on Day 1 followed by once daily dosing for 7 days from Day 4 to Day 10 via a novel dry powder inhaler.
Drug: GSK573719 500 μg
Strip 1 of the dry powder inhaler will contain GSK573719 500 μg micronized drug with lactose along with magnesium stearate. Strip 2 will contain lactose powder along with magnesium stearate. It will be available as dry off white powder for inhalation.
Experimental: GSK573719 1000 μg arm
Each subject will receive the first dose of GSK573719 1000 μg on Day 1 followed by once daily dosing for 7 days from Day 4 to Day 10 via a novel dry powder inhaler.
Drug: GSK573719 1000 μg
Strips 1 and 2 of the dry powder inhaler will contain 500 μg each of GSK573719 micronized drug with lactose along with magnesium stearate. It will be available as dry off white powder for inhalation.
Placebo Comparator: Placebo
Each subject will receive GSK573719 matching placebo on Day 1 followed by once daily dosing for 7 days from Day 4 to Day 10 via a novel dry powder inhaler.
Drug: GSK573719 matching Placebo
Strip 1 and 2 of the dry powder inhaler will contain lactose powder along with magnesium stearate. It will be available as dry off white powder for inhalation.


Outcome Measures

Primary Outcome Measures :
  1. PK: Cmax, tmax and AUC(0-t)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Japanese healthy male subjects aged between 20 and 64 years of age inclusive. Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history, physical examination, laboratory studies, and other tests.
  2. Body weight ≥ 50kg and BMI within the range 18.5-25.0kg/m2 inclusive.
  3. 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))
  4. Normal spirometry (FEV1 ≥ 80% of predicted, FEV1/FVC ≥ 70%).
  5. Clinical laboratory tests data obtained at screening meet the following:

    AST(GOT), ALT(GPT), total-bilirubin: below the upper limit of the normal ranges

  6. Normal 12-lead EGC finding at screening; QTc(B) interval <450msec
  7. A mean blood pressure lower than 140/90mmHg at screening.
  8. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  9. Capable of using the novel dry powder inhaler.

Exclusion Criteria:

  1. The subject has any clinically relevant abnormality on medical examination, vital sign, clinical laboratory test or medical history at screening in the medical opinion of the investigator or the subject has a medical history that is not considered as eligible for inclusion in this study by the investigator.
  2. The subject is positive for syphilis, HBs antigen, HCV antibody, HIV antibody, HTLV-1 antibody.
  3. The subject is positive for urine drug screening.
  4. The subject has an allergy for any drug or idiosyncrasy
  5. The subject has a history of breathing problems (i.e. history of asthmatic symptomatology).
  6. The subject has a history of cardiovascular disease.
  7. The subject has a significant clinical history or current conditions of glaucoma.
  8. The subject has a significant clinical history or current conditions of prostatic hypertrophy.
  9. The subject has a history of drug abuse or alcoholism.
  10. The subject has a history of cholecystectomy or biliary tract disease.
  11. History of regular alcohol consumption exceeding on average, 14 drinks/week (1 drink = 5 ounces (150 mL) of wine or 350 mL of beer or 1.5 ounces (45 mL) of 80 proof distilled spirits) within 6 month of screening.
  12. Use of prescription or non-prescription drugs, including CYP3A/PGP inhibitor, vitamins, herbal and dietary supplements (including St John'sWort) within 14 days prior to the first dose of study medication.
  13. The subject is currently participating in another clinical study or post-marketing study in which the subject is or will be exposed to an investigational or a non-investigational drug or device.
  14. The subject has participated in a clinical study with an investigational or a non-investigational drug or device during the previous 4 months.
  15. The subject has an allergy for any drug hypersensitivity to milk protein or the excipients lactose monohydrate and magnesium stearate.
  16. The subject has donated a unit of blood ">400 mL" within the previous 4 months or ">200 mL" within the previous 1 month.
Contacts and Locations

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): NCT01013974


Locations
Japan
GSK Investigational Site
Kagoshima, Japan, 890-0081
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
More Information

Additional Information:
Study Data/Documents: Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 113377
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: 113377
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 113377
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 113377
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: 113377
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: 113377
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: 113377
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01013974     History of Changes
Other Study ID Numbers: 113377
First Posted: November 16, 2009    Key Record Dates
Last Update Posted: August 3, 2017
Last Verified: August 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.
URL: http://

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