A Blinded, Dose Ascending Study to Assess the Pharmacokinetics, Safety and Tollerability of Repeat Inhaled Doses of Nebulised GW870086X in Healthy Adult Male Volunteers.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-29

Study Completion Date

2010-11-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is a randomised, double-blind, placebo-controlled, dose ascending, 3-way crossover study in healthy adult male volunteers. The primary objective of the study is to assess the pharmacokinetics of 14 days dosing of GW870086X administered via nebules formulation. The secondary objective is to assess the safety and tolerability of repeat doses of nebulised GW870086X.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Evaluate the Effect of Repeat Doses of GW870086X in Mild to Moderate Asthmatics

NCT00945932

Asthma

COMPLETED PHASE2

A Study in Asthmatics to Determine the Efficacy and Dose Response of Repeat Doses of GW870086X on Forced Expiratory Volume in 1 Second (FEV1)

NCT01245426

Asthma

COMPLETED PHASE2

A Study to Evaluate the Effect of GW870086X on Allergen Challenge in Mild Asthmatics

NCT00857857

Asthma

COMPLETED PHASE2

Investigation Of A New Medication (GW642444) In Asthmatic Patients

NCT00354874

Asthma

COMPLETED PHASE2

A Randomized Study To Evaluate The Efficacy And Safety Of An Investigational Drug In Adolescent And Adult Subjects With Asthma Uncontrolled on Low-Dose ICS Therapy.

NCT00603278

Asthma

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

GW870086X is a potent glucocorticoid agonist in human in vitro functional assays that is under development as an inhaled treatment for asthma in children. This study will determine the PK characteristics and assess the safety and tolerability of the nebules formulation of GW870086X in healthy volunteers after 14 days of dosing.

This is the first clinical study that will be assessing the nebules formulation. The purpose of this study is to ensure that the doses that have been selected have a good safety profile in line with what has been found in the previous DPI formulation studies, and to assess the PK profile after single (Day 1) and repeat dose (Day 14) to select appropriate doses for future studies with the nebules formulation. This study will also provide additional safety cover with the nebules formulation given over a longer duration than studied previously with the DPI formulation before moving into the paediatric programme. This study is designed to give at least 5-fold cover for the highest dose to be studied in future paediatric programmes. During this study cortisol production will be assessed by measuring 24 hour cortisol profile in serum and urine as well as performing an ACTH stimulation test. Two doses (5mg and 8.75mg) have been selected. These doses are 5 and 10 times higher than the anticipated maximum clinical dose. The doses have been selected to ensure sufficient safety cover in future paediatric studies as well as to confirm the absence of significant adrenal inhibition at doses that would be expected to cause complete inhibition of cortisol production with traditional steroids.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment Period 1

5mg of GW870086X or placebo will be given once daily for 14 days.

Group Type EXPERIMENTAL

GW870086X

Intervention Type DRUG

5mg and 8.75mg GW870086X once daily for 14 days in separate traetment periods.

Placebo

Intervention Type DRUG

placebo will be randomly inserted into one of the treatment periods following the treatment sequences outlined in the protocol.

Treatment Period 2

GW870086X (5mg or 8.75mg) or placebo will be given once daily for 14 days. In a randomised dose escalating manor following on from treatment period 1.

Group Type EXPERIMENTAL

GW870086X

Intervention Type DRUG

5mg and 8.75mg GW870086X once daily for 14 days in separate traetment periods.

Placebo

Intervention Type DRUG

placebo will be randomly inserted into one of the treatment periods following the treatment sequences outlined in the protocol.

Treatment Period 3

8.75mg of GW870086X or placebo will be given once daily for 14 days.

Group Type EXPERIMENTAL

GW870086X

Intervention Type DRUG

5mg and 8.75mg GW870086X once daily for 14 days in separate traetment periods.

Placebo

Intervention Type DRUG

placebo will be randomly inserted into one of the treatment periods following the treatment sequences outlined in the protocol.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

GW870086X

5mg and 8.75mg GW870086X once daily for 14 days in separate traetment periods.

Intervention Type DRUG

Placebo

placebo will be randomly inserted into one of the treatment periods following the treatment sequences outlined in the protocol.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* A subject will be eligible for inclusion in this study only if all of the following criteria apply:

1. Male between 18 and 65 years of age inclusive, at the time of signing the informed consent.
2. Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
3. AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%).
4. Male subjects must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication until 90-95 hours post-last dose.
5. Body weight, men ≥ 50 kg and BMI within the range 19.0 - 29.0 kg/m2 (inclusive).
6. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
7. Single QTcB or QTcF \< 450 msec; or QTc \< 480 msec in subjects with Bundle Branch Block.

Exclusion Criteria

* A subject will not be eligible for inclusion in this study if any of the following criteria apply:

1. A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
2. Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
3. A positive pre-study drug/alcohol screen.
4. A positive test for HIV antibody.
5. History of regular alcohol consumption within 6 months of the study defined as:

For EU sites: an average weekly intake of \>21 units for males. One unit is equivalent to 8 g of alcohol: a half-pint (\~240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits.
6. 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).
7. Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
8. 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.
9. History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
10. Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
11. Unwillingness or inability to follow the procedures outlined in the protocol.
12. Subject is mentally or legally incapacitated.
13. Subjects who are kept due to regulatory or juridical order in an institution.
14. Subjects who are in military service.
15. History of sensitivity to heparin or heparin-induced thrombocytopenia.
16. Subjects who have asthma or a history of asthma.
17. Subject is a smoker or an ex-smoker with a smoking history of \> 5 pack years (Pack years = (cigarettes per day smoked/20) x number of years smoked)).
18. Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

GSK Investigational Site

Berlin, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Study Documents

Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.