A Study To Investigate Safety, Blood Levels And Effects Of Giving GW642444, By Mouth, By Inhalation & By Injection

NCT00711126 | Completed Phase 1

• 1 other identifier: B2C106180
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

intravenous,; tolerability; pharmacokinetics,; oral,; pharmacodynamics,; safety,; GW642444,; inhaled,

Outcome Measures

Primary Outcomes (1)

• 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

  Various

Secondary Outcomes (2)

• Plasma PK parameters for IV, inhaled and oral routes of administration

  Various

• Urine PK parameters for the intravenous and inhaled routes of administration

  Various

Study Arms (6)

Arm 1

EXPERIMENTAL

HVTs

Drug: GW642444

Arm 2

EXPERIMENTAL

HVTs

Drug: GW642444

Arm 3

EXPERIMENTAL

HVTs

Drug: GW642444

Arm 4

EXPERIMENTAL

HVTs

Drug: GW642444

Arm 5

EXPERIMENTAL

HVTs

Drug: GW642444

Arm 6

EXPERIMENTAL

HVTs

Drug: GW642444

Interventions

GW642444 DRUG

2.5mcg IV

Arm 1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

London, NW10 7NS, United Kingdom

Location

Related Publications (1)

• 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 beta(2)-adrenoceptor agonist for inhalation use in humans. Drug Metab Dispos. 2013 Jan;41(1):89-100. doi: 10.1124/dmd.112.048603. Epub 2012 Oct 4.

  PMID: 23043183 BACKGROUND

Related Links

• Results for study B2C106180 can be found on the GSK Clinical Study Register.
• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2008
• First Posted: July 8, 2008
• Study Start: October 21, 2008
• Primary Completion: December 17, 2008
• Study Completion: December 17, 2008
• Last Updated: July 21, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)