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
  Purpose

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.


Condition Intervention Phase
Healthy Volunteer
Drug: GW642444
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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 -

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 ]

Secondary Outcome Measures:
  • Pharmacodynamics parameters of the systemic β-adrenergic effect (heart rate, blood pressure, QTc, glucose and potassium) [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: September 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LABA Drug: GW642444
Long acting Beta 2 agonist
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 18.5-25.0kg/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.
  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: NCT00964249

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 by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00964249     History of Changes
Obsolete Identifiers: NCT00753701
Other Study ID Numbers: 112017
Study First Received: August 13, 2009
Last Updated: November 25, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

ClinicalTrials.gov processed this record on October 23, 2014