Last updated: 11/04/2018 05:35:34
A Study To Investigate Safety, Blood Levels And Effects Of Giving GW642444, By Mouth, By Inhalation & By Injection
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A single-centre, open-label, sequential, dose-ascending study to examine safety, tolerability, pharmacodynamics and pharmacokinetics of single intravenous, inhaled and oral doses of GW642444 in healthy male subjects
Trial description: This study will involve the use of a new medicine called GW642444 being developed for the treatment of asthma and chronic obstructive pulmonary disease (COPD). The purpose of the study is to see how safe and how well tolerated the study drug is when it is given as a liquid by mouth or by injection into a vein. In addition the study will measure how much of the medicine gets into the bloodstream when it is given by mouth, by injection into a vein and inhaled, and how long the body takes to get rid of it.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Safety and tolerability of GW642444M (key assessments include: measurements of heart rate, blood pressure, electrocardiogram (ECG) (including QTc assessments), lead II monitoring, potassium and glucose, laboratory safety data and review of adverse events
Timeframe: Various
Secondary outcomes:
Plasma PK parameters for IV, inhaled and oral routes of administration
Timeframe: Various
Urine PK parameters for the intravenous and inhaled routes of administration
Timeframe: Various
Interventions:
Enrollment:
9
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Harrell AW, Siederer SK, Bal J, Patel NH, Young GC, Felgate CC, Pearce SJ, Roberts AD, Beaumont C, Emmons AJ, Pereira AI, Kempsford RD. Metabolism and disposition of vilanterol, a long-acting beta2 adrenoreceptor agonist, for inhalation use in human. Drug Metab Dispos. 2013;41(1):89-100.
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
vilanterol
Collaborators
Not applicable
Study date(s)
October 2008 to December 2008
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
- Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with laboratory parameters outside the reference range for this age group may be included only if the Investigator considers the finding will not introduce risk factors and will not interfere with the study procedures.
- Male between 18 and 65 years of age.
- Any clinically relevant abnormality identified at the screening medical assessment (physical examination/medical history), clinical laboratory tests, or ECG.
- A screening Holter ECG tracing that reveals clinically concerning arrhythmias.
Inclusion and exclusion criteria
Inclusion criteria:
- Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with laboratory parameters outside the reference range for this age group may be included only if the Investigator considers the finding will not introduce risk factors and will not interfere with the study procedures.
- Male between 18 and 65 years of age.
- Body weight ≥ 50 kg and Body Mass Index (BMI) within the range 19 – 29.9 kg/m2 (inclusive).
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- No significant abnormality on 12-lead electrocardiogram (ECG) at screening
- Demonstrated ability to use the inhaler device in a satisfactory and repeatable manner.
- Subjects who are current non-smokers who have not used any tobacco products in the 6-month period preceding the screening visit and have a pack history of ≤ 10 pack years.
Exclusion criteria:
- Any clinically relevant abnormality identified at the screening medical assessment (physical examination/medical history), clinical laboratory tests, or ECG.
- A screening Holter ECG tracing that reveals clinically concerning arrhythmias.
- A history of elevated supine blood pressure or a mean supine blood pressure persistently equal to or higher than 140/90 mmHg at screening.
- A mean heart rate outside the range 45– 90 beats per minute (bpm) at screening.
- Where participation in the study would result in donation of blood in excess of 500 millilitres (mL) within a 3 month period.
- The subject has participated in a clinical study with a New Chemical Entity (NCE), or any other drug within a clinical study, within the past 3 months.
- The subject has a history of drug or other allergy, which, in the opinion of the responsible physician, contraindicates their participation.
- Any adverse reaction including immediate or delayed hypersensitivity to any β2 (beta) agonist or sympathomimetic drug, or known or suspected sensitivity to the constituents of GW642444 inhalation powder (for example; lactose, magnesium stearate).
- The subject has a positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening (with the exception of phase I hepatic impairment studies, oncology studies, hepatitis, hepatic fibrosis, or Human Immunodeficiency Virus (HIV) studies).
- A positive test for HIV antibody.
- History of regular alcohol consumption within 6 months of the study defined as:
- an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units. One unit is equivalent to a half-pint (220mL) of beer or 1 (25mL) measure of spirits or 1 glass (125mL) of wine.
- 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).
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- 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.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Urinary cotinine levels (or Carbon Monoxide (CO) breath monitoring) indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
- Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pommelos, 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
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2008-17-12
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 B2C106180 can be found on the GSK Clinical Study Register.
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