Last updated: 11/07/2018 04:18:25
Phase I study of GW642444M 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 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 -
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Safety：adverse events, vital sign, ECGs, and clinical laboratory test
Timeframe: N/A
PK：Cmax, tmax and AUC(0-t)
Timeframe: N/A
Secondary outcomes:
Pharmacodynamics parameters of the systemic β-adrenergic effect (heart rate, blood pressure, QTc, glucose and potassium)
Timeframe: N/A
Interventions:
Drug: GW642444
Drug: Placebo
Enrollment:
32
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical 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;ePub ahead of print ahead of print.
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
vilanterol
Collaborators
Not applicable
Study date(s)
September 2008 to December 2008
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 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.
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.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.
Trial location(s)
Study documents
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
2008-01-12
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
Results for study 112017 can be found on the GSK Clinical Study Register.
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