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Pulmonary Disease, Chronic ObstructivePhase 1NCT00711126

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

A Phase 1 study testing GW642444 in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
GW642444
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteUnited Kingdom
Study dates
21 Oct 2008to 17 Dec 2008
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.
  • Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
  • Unwillingness or inability to follow the procedures outlined in the protocol.
  • Urinary cotinine levels (or Carbon Monoxide (CO) breath monitoring) indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
  • Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pommelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • GSK Investigational Site

    London, NW10 7NS

Other trials in United Kingdom

About this study

Official title: A Single-centre, Open-label, Sequential, Dose-ascending Study to Examine Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single Intravenous, Inhaled and Oral Doses of GW642444 in Healthy Male Subjects

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.

Read the detailed description

This will be a single-centre, open-label, dose-ascending study in 9 healthy male subjects to establish safe and well tolerated systemic exposure safety margins for GW642444 following intravenous and oral dosing to support future studies. Additionally a single inhaled dose of GW642444M will be administered to provide data to estimate inhaled bioavailability of GW642444 and the extent of renal excretion following dosing via this route. It is planned to administer four, dose-ascending, intravenous administrations of GW642444 during treatment periods 1, 2, 3 and 5; the inhaled dose would be administered in treatment period 4 and the oral dose in treatment period 6. The sequence of treatment administration may be altered if required for logistical reasons, however doses of intravenous and oral GW642444 will be administered strictly in dose ascending order. All intravenous doses will be administered as an infusion given at a constant rate over a 1 hour period.

Being tested
GW642444
Keywords
intravenous,, tolerability, pharmacokinetics,, oral,, pharmacodynamics,, safety,, GW642444,, inhaled,
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Respiratory Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GW642444Drug

    2.5mcg IV

  • GW642444Drug

    5mcg IV

  • GW642444Drug

    10mcg IV

  • GW642444Drug

    100mcg inhaled

  • GW642444Drug

    20mcg IV

  • GW642444Drug

    500mcg oral

Study groups in NCT00711126
Study groupRoleWhat they receive
Arm 1ExperimentalHVTs
Receives: Drug: GW642444
Arm 2ExperimentalHVTs
Receives: Drug: GW642444
Arm 3ExperimentalHVTs
Receives: Drug: GW642444
Arm 4ExperimentalHVTs
Receives: Drug: GW642444
Arm 5ExperimentalHVTs
Receives: Drug: GW642444
Arm 6ExperimentalHVTs
Receives: Drug: GW642444

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Various

Secondary outcomes (2)

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

    Measured: Various

  2. Urine PK parameters for the intravenous and inhaled routes of administration

    Measured: Various

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2008 (estimated)
  2. Study start21 Oct 2008
  3. Primary completion17 Dec 2008
  4. Study completion17 Dec 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00711126
Sponsor's protocol ID
B2C106180
Status last verified
Jul 2017
First submitted
3 Jul 2008
Last updated
21 Jul 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • 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.

    PubMed 23043183

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GW642444 in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Various). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00711126, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.

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