Effect of GSK704838 In Healthy Volunteers

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00539825
• Date of registration: 04/10/2007
• Primary sponsor: GlaxoSmithKline
• Public title: Effect of GSK704838 In Healthy Volunteers
• Scientific title: A Randomized Double-blind, Placebo-controlled, Crossover, Dose Escalation Study to Examine the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single Inhaled Doses of GSK704838 and Tiotropium Bromide
• Date of first enrolment: September 2007
• Target sample size: 20
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00539825
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Countries of recruitment

United Kingdom

Contacts

• Name: GSK Clinical Trials, MD, MSc, FFPM
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy male subject

- Aged between 18-55 years inclusive.

- Non-smokers

- Normal spirometry

- A signed and dated written informed consent is obtained from the subject.

- The subject is capable of giving informed consent, which includes compliance with the
requirements and restrictions listed in the consent form.

- Available to complete the study.

- The subject is =50kg with a body mass index within the range 19.0 to 29.9 kg/m2
inclusive.

- Response to ipratropium bromide

Exclusion Criteria:

- Any clinically relevant and important abnormality identified at the screening medical
assessment (physical examination/medical history), clinical laboratory tests, or ECG
(12-lead or Holter).

- A history of breathing problems

- A mean QTc(B) value > 450ms, the QTc(B) of the 3 screening ECGs are not within 10% of
the mean, a PR interval outside the range 90-210ms or an ECG that is not suitable for
QT measurements at screening.

- A history of elevated resting blood pressure or a mean blood pressure higher than
140/90 mmHg at screening.

- A mean heart rate outside the range 40-90 bpm inclusive at screening.

- History of use of tobacco- or nicotine-containing products within 6 months of
screening, and/or positive urine cotinine test results at screening.

- Where participation in the study would result in donation of blood in excess of 500mL
within a 56 day period at screening.

- The subject is currently taking regular (or a course of) medication, whether
prescribed or not, including herbal remedies such as St John's Wort etc.

The subject has taken:

- prescription medications for 14 days prior to first dose of study drug, or

- Over-the-counter (OTC) medications/preparations (including herbal remedies, etc.)
excluding simple analgesics for 48 hours prior to first dose of study drug, unless it
is judged by the Investigator not to compromise the subject's safety or influence the
outcome of the study.

- The subject has participated in a study with a new molecular entity or any other
trial within a period of 3 months prior first dose of study drug.

- The subject has tested positive for hepatitis C antibody (third generation
enzyme immunoassay), hepatitis B surface antigen or HIV antibodies (if tested
according to site SOP's) at screening.

- The subject has tested positive for drugs-of-abuse at screening.

- The subject has tested positive for urine alcohol (including ethanol) at
screening.

The detection of alcohol would not be an exclusion at screening but would need to be
negative pre-dose and during the study.

- The subject is unable to use the DISKUS™ and/or HandiHaler inhaler devices correctly
at screening.

- The subject has a suspected history of alcohol abuse within the six months previous
to the screening visit.

- The subject has a known allergy or hypersensitivity to magnesium stearate, milk
protein or the excipient lactose monohydrate, iodine, ipratropium bromide, tiotropium
bromide, atropine and/or any of its derivatives.

- The subject has a significant clinical history of prostatic hypertrophy or narrow
angle glaucoma.

- The subject has received an allogeneic bone marrow transplant.

- The subject has claustrophobia that may be aggravated by entering the whole body
plethysmography cabinet.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Chronic Obstructive Pulmonary Disease (COPD)

Intervention(s)

Drug: GSK704838

Primary Outcome(s)

adverse events, vital signs,12-lead ECG, Holter and ECG monitoring,lung function and clinical lab tests. These will be taken pre-dose and at multiple time points up to 48h at each treatment period.

Secondary Outcome(s)

- Plasma and urine concentrations of GSK704838 and derived pharmacokinetic parameters over 48h post-dose. - Serial sGaw, Raw and FEV1 measurements over 24h post-dose.

Serial sGaw measurements over 48 hours for the last period in each cohort dose of GSK704838 and tiotropium bromide.

Serial specific airway conductance (sGaw), Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity measurements (FVC) over 24 hours post-dose of GSK704838 and tiotropium bromide.

Secondary ID(s)

AC6108697

Source(s) of Monetary Support

Please refer to primary and secondary sponsors