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A Study of GW685698X in Healthy Japanese Male Subjects

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: NCT00972673
Recruitment Status : Completed
First Posted : September 7, 2009
Last Update Posted : August 3, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE September 3, 2009
First Posted Date  ICMJE September 7, 2009
Last Update Posted Date August 3, 2017
Actual Study Start Date  ICMJE September 24, 2008
Actual Primary Completion Date December 19, 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 3, 2009)
  • safety: adverse events, vital sign, ECGs, and clinical laboratory test
  • PK: Cmax, tmax and AUC(0-t)
  • PD: serum cortisol
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of GW685698X in Healthy Japanese Male Subjects
Official Title  ICMJE Phase I Study of GW685698X-A Randomized, Double Blind, Placebo Controlled, Parallel-group, Repeat Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled Dose From a Novel Dry Powder Device in Healthy Japanese Male Subjects.
Brief Summary This is a randomized, double blind, placebo controlled, parallel-group, repeat dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of inhaled dose from a novel dry powder device in healthy Japanese male subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Asthma
Intervention  ICMJE
  • Drug: Placebo
    comparator
  • Drug: GW685698X
    Inhaled steroid
Study Arms  ICMJE
  • Experimental: arm 1
    In Arm 1 subjects will receive 200, 400 or 800 microgram of powdered inhalation of GW685698X once daily for 7 days from Day 5 to Day 11.
    Intervention: Drug: GW685698X
  • Placebo Comparator: arm 2
    In Arm 2 subjects will receive Placebo powdered inhalation once daily for 7 days from Day 5 to Day 11.
    Intervention: Drug: Placebo
Publications * Nakahara N, Wakamatsu A, Kempsford R, Allen A, Yamada M, Nohda S, Hirama T. The safety, pharmacokinetics and pharmacodynamics of a combination of fluticasone furoate and vilanterol in healthy Japanese subjects. Int J Clin Pharmacol Ther. 2013 Aug;51(8):660-71. doi: 10.5414/CP201822.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 3, 2009)
48
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 19, 2008
Actual Primary Completion Date December 19, 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.
  • Body weight ≥ 50kg and BMI within the range 18.5-25.0kg/m2 inclusive.
  • 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))
  • Clinical laboratory tests data obtained at screening meet the following:

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

  • Normal 12-lead EGC finding at screening; QTc(B) interval <450msec
  • Normal spirometry (FEV1 ≥ 80% of predicted, FEV1/FVC ≥ 70%).
  • Rapid ACTH with normal range at the screening.
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  • Capable of using the novel dry powder inhaler.

Exclusion Criteria:

  • 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.
  • The subject has an allergy for any drug or idiosyncrasy
  • The subject has an allergy for any drug hypersensitivity to milk protein or the excipients lactose monohydrate and magnesium stearate.
  • T he 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.
  • The subject has participated in a clinical study with an investigational or a non-investigational drug or device during the previous 4 months.
  • The subject has a history or current conditions of drug abuse or alcoholism.
  • 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.
  • The subject is positive for urine drug at screening.
  • 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.
  • The subject has a known allergy or hypersensitivity to corticosteroids.
  • The subject has a known allergy or hypersensitivity to synthetic ACTH
  • The subject has a history of asthma in childhood or respiratory disorder.
  • The subject is a permanent (or occasional during the study) night-shift worker*.

    * Permanent night shift worker defines as the person who has been continuing life that gets up after 12:00 day time and eats supper after 0:00 midnight for seven days or more usually.

  • The subject is positive for syphilis, HBs antigen, HCV antibody, HIV antibody, HTLV-1 antibody.
  • The subject has donated a unit of blood ">400mL" within the previous 4 months or ">200mL" within the previous 1 month.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00972673
Other Study ID Numbers  ICMJE 112018
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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.
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP