Overview

Effect of GSK1160724 In Healthy Volunteers

Status:
Completed
Trial end date:
2008-04-07
Target enrollment:
0
Participant gender:
All
Summary
GSK1160724 is a potent mAChR antagonist, which is being developed for treatment of chronic obstructive pulmonary disease (COPD)
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Bromides
Tiotropium Bromide
Criteria
Inclusion Criteria:

- Healthy male and female subjects. Female subjects must be of non-child bearing
potential.

- 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 greater than or equal to 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