Clinical trial NCT00803673: A Healthy Volunteer Study With Inhaled GSK573719 and Placebo
Official title: A Single Centre, Randomized, Double-blind, Dose Ascending, Placebo-controlled Study, in Two Parts, to Evaluate the Safety, Tolerability and Pharmacokinetics of Escalating Single and Repeat Inhaled Doses of GSK573719 and Placebo Formulated With the Excipient Magnesium Stearate, in Healthy Subjects and in a Healthy Population of Cytochrome P450 Isoenzyme 2D6 Poor Metabolisers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Healthy volunteers
New formulation
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-12-05
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is to look at a new formulation of GSK573719 to see if it is safe and tolerated in healthy volunteers


Eligibility criteria: Inclusion Criteria:

* Healthy.
* Male or female 18 to 65 years of age inclusive.
* Non-childbearing women or women of child bearing potential who agree to use contraception
* Subject has had their CYP2D6 genotype confirmed and can be included in either of the following parts:
* Part 1: may include extensive, intermediate and ultra-rapid metabolizers
* Part 2: includes only poor (no enzyme activity) metabolizers, with previously confirmed phenotype
* Body Mass Index within the range 18 - 30 kg/m2 (inclusive).
* Capable of giving written informed consent
* Normal ECG;
* Normal lung function.
* 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))
* A signed and dated written informed consent is obtained from the subject
* The subject is capable of giving informed consent
* Available to complete the study

Exclusion Criteria:

* Any clinically important abnormality identified at the screening medical assessment (physical examination/medical history), clinical laboratory tests, or ECG (12-lead). 24hr Holter monitoring outside normal limits.
* A history of breathing problems (i.e. history of asthmatic symptomatology).
* Abnormal ECG.
* Abnormal blood pressure.
* Abnormal heart rate
* The subject has a positive pre-study drug/alcohol screen.
* A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within three months of screening.
* A positive test for HIV antibody (if determined by the local SOPs).
* History of high alcohol consumption within three months of the study
* The subject has participated in a clinical trial and has received an IP within the following time period prior to the first dosing day in the current study: 30 days, five half-lives or twice the duration of the biological effect of the IP (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, (except for simple analgesics e.g. paracetamol), including vitamins, herbal and dietary supplements (including St John's Wort) within seven days (or 14 days if the drug is a potential enzyme inducer) or five half-lives (whichever is longer) prior to the first dose of study medication
* 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.
* Where participation in the study would result in donation of blood or blood products in excess of 500mL within a 56 day period.
* Unwillingness or inability to follow the procedures outlined in the protocol.
* Urinary cotinine levels indicative of smoking or history of regular use of tobacco- or nicotine-containing products prior to screening.
* The subject is unable to use the novel dry powder inhaler correctly.
* The subject has a known allergy or hypersensitivity to milk protein or the excipients magnesium stearate and lactose monohydrate.

Primary outcomes:
measure: General safety and tolerability endpoints: Adverse Events (AE), HR, BP, 12- lead ECG and lung function (FEV1) and clinical laboratory safety tests
timeFrame: Various
Secondary outcomes:
measure: Blood and urine levels of study drug
timeFrame: various
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Cahn A, Mehta R, Preece A, Blowers J, Donald A. Safety, tolerability and pharmacokinetics and pharmacodynamics of inhaled once-daily umeclidinium in healthy adults deficient in CYP2D6 activity: a double-blind, randomized clinical trial. Clin Drug Investig. 2013 Sep;33(9):653-64. doi: 10.1007/s40261-013-0109-6.