AsthmaPhase 1NCT00549497
A Randomized Study Evaluating Steroid Hormone Levels, Safety And Tolerability Of GW870086X In Healthy Volunteers
A Phase 1 study testing GW870086X in people with Asthma, run by GlaxoSmithKline at 1 site in Australia.
Trial summary
GW870086X is a novel inhaled steroid that has an improved safety profile over other steroids but is also less potent. This study will look at higher doses to confirm the improved safety profile. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- GW870086X
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteAustralia
- Study dates
- Sep 2007to Jan 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects
- Liver function tests normal
- 18 - 45 years old
- Non smoker
- Can provide written informed consent
- Available to complete the whole trial
- Can use the inhalation device correctly
- Able to read, understand and write English
Who cannot join
- Deemed suitable healthy subject
- History to sensitivity to the study medication
- Any history of breathing problems in adult life
- Participated in another trial within 30 days or 5 half-lives of the new chemical entity
- Exposed to more than 4 new chemical entities within 12 months
- Donated >500 mL blood within 2 months of screening
Show all 16Show fewer
- Haemoglobin level < 13g/dl
- Use of prescription or non-prescription drugs within 7 days of first dose
- Taking drugs that significantly inhibit cytochrome P450 subfamily enzyme CYP3A4
- Drinks more than 4 units a day or 28 units a week
- Cannot use DISKHALER device correctly
- Positive HepB, HepC within 3 months of screening
- Positive HIV test
- Positive pre study drug/alcohol screen
- Significant cardiac conduction abnormalities
- Risk of non-compliance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Dose Ascending, 3-cohort Parallel Group Study to Measure the Systemic Cortisol Profile and Evaluate the Safety, Tolerability and Pharmacokinetics of GW870086X, Administered as Single Doses (12mg and 15mg), and Repeat Doses Over 3 Days (6mg, 12mg and 15mg) in Healthy Male Subjects
GW870086X is a novel inhaled steroid that has an improved safety profile over other steroids but is also less potent. This study will look at higher doses to confirm the improved safety profile.
Read the detailed description
A randomized, double-blind, placebo-controlled, dose ascending, 3-cohort parallel group study to measure the systemic cortisol profile and evaluate the safety, tolerability and pharmacokinetics of GW870086X, administered as single doses (12mg and 15mg),and repeat doses over 3 days (6mg, 12mg and 15mg) in healthy male subjects.
- Conditions
- Asthma
- Being tested
- GW870086X
- Keywords
- GW870086X, inhaled, asthma, cortisol, pharmacokinetics, osteocalcin
- Medical subject headings
- Asthma, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW870086XDrug
| Study group | Role | What they receive |
|---|---|---|
| GW870086X | Other | Not described Receives: Drug: GW870086X |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of GW870086X on cortisol levels (naturally produced steroid hormone) in the body during a single dose and after 3 days of dosing
Measured: 3 days
Secondary outcomes (9)
Safety & tolerability measures: heart rate, blood pressure, ECG, safety laboratory tests, lung function
Measured: 3 days
Total urinary free cortisol excretion
Measured: over 24 hours on Day 1 and Day 3.
Serum osteocalcin weighted mean
Measured: over 24 hours on Day 3.
Fasting glucose
Measured: on Day 1
mRNA steroid responsive gene panel
Measured: 3 days
Plasma concentrations of GW870086X and GW870086X pharmacokinetic parameters (including AUC, Cmax, t1/2 and tmax).
Measured: 3 days
Plasma concentrations of GW870086X and derived pharmacokinetic parameters
Measured: 3 days
Cortsiol urine concentrations
Measured: 3 days
Osteocalcin serum concentrations
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00549497
- Sponsor's protocol ID
- SIG110405
- Status last verified
- Feb 2011
- First submitted
- 24 Oct 2007
- Last updated
- 3 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Dolle S, Hielscher N, Bareille PJ, Hardes K, Robertson J, Worm M. Clinical efficacy and tolerability of a novel selective corticosteroid in atopic dermatitis--two randomised controlled trials. Skin Pharmacol Physiol. 2015;28(3):159-66. doi: 10.1159/000367696. Epub 2015 Jan 20.
PubMed 25614148
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Dose Ascending, 3-cohort Parallel Group Study to Measure the Systemic Cortisol Profile and Evaluate the Safety, Tolerability and Pharmacokinetics of GW870086X, Administered as Single Doses (12mg and 15mg), and Repeat Doses Over 3 Days (6mg, 12mg and 15mg) in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT00549497
- Acronym / sponsor ID
- SIG110405
- Conditions
- Asthma
- Keywords
- GW870086X, inhaled, asthma, cortisol, pharmacokinetics, osteocalcin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2007 (actual)
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 25 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
GW870086X is a novel inhaled steroid that has an improved safety profile over other steroids but is also less potent. This study will look at higher doses to confirm the improved safety profile.
Detailed description
A randomized, double-blind, placebo-controlled, dose ascending, 3-cohort parallel group study to measure the systemic cortisol profile and evaluate the safety, tolerability and pharmacokinetics of GW870086X, administered as single doses (12mg and 15mg),and repeat doses over 3 days (6mg, 12mg and 15mg) in healthy male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GW870086X | Other | Drug: GW870086X |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy male subjects
- Liver function tests normal
- 18 - 45 years old
- Non smoker
- Can provide written informed consent
Key exclusion criteria (16 listed)
- Deemed suitable healthy subject
- History to sensitivity to the study medication
- Any history of breathing problems in adult life
- Participated in another trial within 30 days or 5 half-lives of the new chemical entity
- Exposed to more than 4 new chemical entities within 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GW870086X | Drug | GW870086X |
Primary outcome
Effect of GW870086X on cortisol levels (naturally produced steroid hormone) in the body during a single dose and after 3 days of dosing
Time frame: 3 days
9 secondary outcomes
Safety & tolerability measures: heart rate, blood pressure, ECG, safety laboratory tests, lung function
Time frame: 3 days
Total urinary free cortisol excretion
Time frame: over 24 hours on Day 1 and Day 3.
Serum osteocalcin weighted mean
Time frame: over 24 hours on Day 3.
Fasting glucose
Time frame: on Day 1
mRNA steroid responsive gene panel
Time frame: 3 days
Plasma concentrations of GW870086X and GW870086X pharmacokinetic parameters (including AUC, Cmax, t1/2 and tmax).
Time frame: 3 days
Plasma concentrations of GW870086X and derived pharmacokinetic parameters
Time frame: 3 days
Cortsiol urine concentrations
Time frame: 3 days
Osteocalcin serum concentrations
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2017.
- Derived from this study: PubMed 25614148Dolle S, Hielscher N, Bareille PJ, Hardes K, Robertson J, Worm M. Clinical efficacy and tolerability of a novel selective corticosteroid in atopic dermatitis--two randomised controlled trials. Skin Pharmacol Physiol. 2015;28(3):159-66. doi: 10.1159/000367696. Epub 2015 Jan 20.
Related trials for Asthma
Active, not recruitingPhase 3
A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma
Asthma
Not yet recruitingPhase 1
Study of HXN-1013 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Health Adults, Asthma
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 1
A Phase 1 Trial of AMG 691 in Healthy Chinese and Japanese Volunteers
Healthy Participants
RecruitingPhase 1/2
A Study of HB0056 in Adult Participants With Moderate to Severe Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GW870086X in people with Asthma, run by GlaxoSmithKline at 1 site in Australia.
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 8 inclusion and 16 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 3 Feb 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 Australia. 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?
Effect of GW870086X on cortisol levels (naturally produced steroid hormone) in the body during a single dose and after 3 days of dosing (time frame: 3 days). 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 NCT00549497, 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 3 Feb 2017.