Effect of GSK1160724 In Healthy Volunteers

NCT ID: NCT00555022

Last Updated: 2017-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-12
• Study Completion Date: 2008-04-07

Brief Summary

GSK1160724 is a potent mAChR antagonist, which is being developed for treatment of chronic obstructive pulmonary disease (COPD)

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT

Study Groups

All subjects

Eligible subjects will receive one of the following treatment in cohort I and cohort II in five different treatment periods; Placebo, GSK1160724 (10 micrograms, 50 micrograms or 125 micrograms) and tiotropium bromide

Group Type: EXPERIMENTAL

GSK1160724

Intervention Type: DRUG

GSK1160724 will be available with dosing strengths of 10, 50 and 125 micrograms/blister for inhalation using the DISKUS inhaler.

Tiotropium bromide

Intervention Type: DRUG

Tiotropium bromide capsules will be supplied with a dose of 18 micrograms administered via a HandiHaler device.

Placebo

Intervention Type: DRUG

Subjects will receive placebo.

Interventions

GSK1160724

GSK1160724 will be available with dosing strengths of 10, 50 and 125 micrograms/blister for inhalation using the DISKUS inhaler.

Intervention Type: DRUG

Tiotropium bromide

Tiotropium bromide capsules will be supplied with a dose of 18 micrograms administered via a HandiHaler device.

Intervention Type: DRUG

Placebo

Subjects will receive placebo.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Harrow, Middlesex, United Kingdom

Countries

United Kingdom

Other Identifiers

AC5108696

Identifier Type: -

Identifier Source: org_study_id