Last updated: 11/07/2018 05:47:39
A blinded, dose ascending study to assess the pharmacokinetics, safety and tollerability of repeat inhaled doses of nebulised GW870086X in healthy adult male volunteers.SIG
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A randomised, double-blind, placebo-controlled, dose ascending,3-way crossover study to assess the pharmacokinetics, safety andtolerability of repeat inhaled doses of nebulised GW870086X inhealthy adult male volunteers.
Trial description: This study is a randomised, double-blind, placebo-controlled, dose ascending, 3-waycrossover study in healthy adult male volunteers. The primary objective of the study is toassess the pharmacokinetics of 14 days dosing of GW870086X administered via nebulesformulation. The secondary objective is to assess the safety and tolerability of repeatdoses of nebulised GW870086X.
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Allocation:
Randomized
Primary outcomes:
Plasma concentrations of GW870086X and GW870086X pharmacokinetic parameters (including AUC, Cmax, t1/2 and tmax)
Timeframe: 3 months
Secondary outcomes:
Adverse Events
Timeframe: 3 months
Clinically relevant changes in safety parameters:Clinical laboratory tests (clinical chemistry, haematology, urinalysis), 12-Lead ECG data; including QT, QTc, HR, QRS and RR intervals, Vital signs: systolic and diastolic blood pressure, pulse rate
Timeframe: 3 months
Serum cortisol weighted mean over 24 hours
Timeframe: 3 months
Urine cortisol excretion over 24 hours
Timeframe: 3 months
ACTH stimulation test (Period 3 only)
Timeframe: 3 months
Interventions:
Drug: GW870086X
Drug: Placebo
Enrollment:
12
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Allen A, Bareille P, Hardes K, Robertson J. Safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat doses of GW870086. Clin Pharmacol Drug Devel. 2013;8(2):
Medical condition
Asthma
Product
GW870086
Collaborators
Not applicable
Study date(s)
July 2010 to November 2010
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
- A subject will be eligible for inclusion in this study only if all of the following criteria
- apply:
- A subject will not be eligible for inclusion in this study if any of the following criteria
- apply:
Inclusion and exclusion criteria
Inclusion criteria:
- A subject will be eligible for inclusion in this study only if all of the following criteria apply: 1. Male between 18 and 65 years of age inclusive, at the time of signing the informed consent. 2. Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. 3. AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). 4. Male subjects must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication until 90-95 hours post-last dose. 5. Body weight, men ≥ 50 kg and BMI within the range 19.0 – 29.0 kg/m2 (inclusive). 6. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. 7. Single QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.
Exclusion criteria:
- A subject will not be eligible for inclusion in this study if any of the following criteria apply: 1. A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening. 2. Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). 3. A positive pre-study drug/alcohol screen. 4. A positive test for HIV antibody. 5. History of regular alcohol consumption within 6 months of the study defined as: For EU sites: an average weekly intake of >21 units for males. One unit is equivalent to 8 g of alcohol: a half-pint (~240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits. 6. The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). 7. Exposure to more than four new chemical entities within 12 months prior to the first dosing day. 8. Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John’s Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety. 9. History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation. 10. Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period. 11. Unwillingness or inability to follow the procedures outlined in the protocol. 12. Subject is mentally or legally incapacitated. 13. Subjects who are kept due to regulatory or juridical order in an institution. 14. Subjects who are in military service. 15. History of sensitivity to heparin or heparin-induced thrombocytopenia. 16. Subjects who have asthma or a history of asthma. 17. Subject is a smoker or an ex-smoker with a smoking history of > 5 pack years (Pack years = (cigarettes per day smoked/20) x number of years smoked)). 18. Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.
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
2010-05-11
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.
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