Phase I Study of GW642444M in Healthy Japanese Male Subjects

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00964249
First received: August 13, 2009
Last updated: November 25, 2009
Last verified: November 2009

August 13, 2009
November 25, 2009
September 2008
November 2008   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00964249 on ClinicalTrials.gov Archive Site
Pharmacodynamics parameters of the systemic β-adrenergic effect (heart rate, blood pressure, QTc, glucose and potassium) [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Phase I Study of GW642444M in Healthy Japanese Male Subjects
Phase I Study of GW642444M - A Randomized, Double Blind, Placebo Controlled, Parallel-group, 7 Day Repeat Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled Dose of GW642444M From a Novel Dry Powder Device in Healthy Japanese Male Subjects -

This is a randomized, double blind, placebo controlled, parallel-group, 7 day repeat dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of inhaled dose of GW642444M from a novel dry powder device in healthy Japanese male subjects.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Healthy Volunteer
  • Drug: GW642444
    Long acting Beta 2 agonist
  • Drug: Placebo
    Matching placebo
  • Experimental: LABA
    Intervention: Drug: GW642444
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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.
 
Completed
32
November 2008
November 2008   (final data collection date for primary outcome measure)

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. Serum potassium and glucose within normal range at screening
  7. Normal 12-lead EGC finding at screening; QTc interval <450msec
  8. A mean heart rate within the range 40-90 beats per minute (bpm) inclusive at screening.
  9. A mean blood pressure lower than 140/90mmHg at screening.
  10. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  11. 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 an allergy for any drug or idiosyncrasy
  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. 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.
  11. The subject is positive for syphilis, HBs antigen, HCV antibody, HIV antibody, HTLV-1 antibody.
  12. The subject has donated a unit of blood ">400mL" within the previous 4 months or ">200mL" within the previous 1 month.
Male
20 Years to 64 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00964249
112017
Not Provided
Study Director, GSK
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
November 2009

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