Last updated: 11/03/2018 12:28:58
Phase I study of GSK233705 in healthy Japanese male subjects
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Phase I study of GSK233705- A randomised, double blind, placebo-controlled, 2-parts study to investigate the safety, tolerability, and pharmacokinetics of single and repeat inhaled doses of GSK233705 from a novel dry powder device in healthy Japanese male subjects -
Trial description: This is a randomised, double blind, placebo-controlled, 2-parts study to investigate the safety, tolerability, and pharmacokinetics of single and repeat inhaled doses of GSK233705 from a novel dry powder device in healthy Japanese male subjects.
Primary purpose:
Prevention
Trial design:
Crossover 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:
Not applicable
Interventions:
Enrollment:
28
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
This study has not been published in the scientific literature.
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
darotropium bromide
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 18.50-25.00kg/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 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 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 a known allergy or hypersensitivity to ipratropium bromide, tiotropium, atropine and any of its derivatives. 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.The subject is positive for syphilis, HBs antigen, HCV antibody, HIV antibody, HTLV-1 antibody. 11.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
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2008-20-12
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
Participate in clinical trial
Additional information
Results for study 112016 can be found on the GSK Clinical Study Register.
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