Last updated: 11/07/2018 05:58:59
A study of GSK573719 in healthy Japanese male subjects
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
PK: Cmax, tmax and AUC(0-t)
Timeframe: N/A
Secondary outcomes:
Not applicable
Interventions:
Drug: GSK573719 250 μg
Drug: GSK573719 500 μg
Drug: GSK573719 1000 μg
Drug: GSK573719 matching Placebo
Enrollment:
48
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Nakahara N, Takahashi N, Kelleher D, Mehta R. Safety, tolerability and pharmacokinetics (PK) of single and repeat doses of GSK573719 in healthy Japanese subjects. Am J Respir Crit Care Med. 2012;185(Meeting Abstracts):A2915.
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
umeclidinium bromide
Collaborators
Not applicable
Study date(s)
October 2009 to December 2009
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
20 - 64 years
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion 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.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2009-18-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
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