Phase I Study of GSK233705 in Healthy Japanese Male Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00964405
First received: August 13, 2009
Last updated: June 21, 2012
Last verified: February 2011
  Purpose

This is a randomised, double blind, placebo-controlled, 2-parts study to investigate the safety, tolerability, and pharmacokinetics of single and repeat inhaled doses of GSK233705 from a novel dry powder device in healthy Japanese male subjects.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Healthy Volunteer
Drug: GSK233705
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase I Study of GSK233705 - A Randomised, Double Blind, Placebo-controlled, 2-parts Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Inhaled Doses of GSK233705 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:
  • Safety:adverse events, vital sign, ECGs, and clinical laboratory test [ Designated as safety issue: No ]
  • PK:Cmax, tmax and AUC(0-t) [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: September 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LAMA Drug: GSK233705
Inhaled Long acting muscarinic receptor antagonist
Placebo Comparator: Placebo Drug: Placebo
Matching placebo

  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 18.50-25.00kg/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 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 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.
  3. The subject has participated in a clinical study with an investigational or a non-investigational drug or device during the previous 4 months.
  4. A history of breathing problems (i.e. history of asthmatic symptomatology, asthma in childhood).
  5. The subject has a known allergy or hypersensitivity to ipratropium bromide, tiotropium, atropine and any of its derivatives.
  6. The subject has a known allergy or hypersensitivity to milk protein or the excipients lactose monohydrate and magnesium stearate.
  7. The subject has a history or current conditions of drug abuse or alcoholism.
  8. History of regular alcohol consumption exceeding on average, 14 drinks/week (1 drink=5 ounces (150mL) of wine or 350mL of beer or 1.5 ounces (45mL) of 80 proof distilled spirits) within 6 month of screening.
  9. The subject is positive for urine drug screening.
  10. The subject is positive for syphilis, HBs antigen, HCV antibody, HIV antibody, HTLV-1 antibody.
  11. The subject has donated a unit of blood ">400mL" within the previous 4 months or ">200mL" 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: NCT00964405

Locations
Japan
GSK Investigational Site
Fukuoka, Japan, 812-0025
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00964405     History of Changes
Other Study ID Numbers: 112016
Study First Received: August 13, 2009
Last Updated: June 21, 2012
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 20, 2014