A Study of GSK573719 in Healthy Japanese Male Subjects

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01013974
First received: November 12, 2009
Last updated: March 24, 2011
Last verified: March 2011
  Purpose

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 Intervention Phase
Pulmonary Disease, Chronic Obstructive
Healthy Volunteer
Drug: GSK573719
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 -

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • PK: Cmax, tmax and AUC(0-t) [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: October 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: arm 1 Drug: GSK573719
Inhaled micronised drug
Placebo Comparator: arm 2 Drug: Placebo
Lactose powder and containing magnesium stearate

  Eligibility

Ages Eligible for Study:   20 Years to 64 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01013974

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

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01013974     History of Changes
Other Study ID Numbers: 113377
Study First Received: November 12, 2009
Last Updated: March 24, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on July 22, 2014