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AsthmaPhase 1SIGNCT01160003

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

A Phase 1 study testing GW870086X in people with Asthma, run by GlaxoSmithKline at 1 site in Germany.

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 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. 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
Asthma
What is being tested?
GW870086X
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
12 participants
Where
1 siteGermany
Study dates
29 Jul 2010to 5 Nov 2010
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

  • A subject will be eligible for inclusion in this study only if all of the following criteria apply:
  • Male between 18 and 65 years of age inclusive, at the time of signing the informed consent.
  • 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.
  • AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
  • 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.
  • Body weight, men ≥ 50 kg and BMI within the range 19.0 - 29.0 kg/m2 (inclusive).
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  • Single QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.

Who cannot join

  • A subject will not be eligible for inclusion in this study if any of the following criteria apply:
  • A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
  • Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • A positive pre-study drug/alcohol screen.
  • A positive test for HIV antibody.
  • History of regular alcohol consumption within 6 months of the study defined as:
Show all 20Show fewer
  • 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.
  • 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.
  • 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.
  • Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
  • Unwillingness or inability to follow the procedures outlined in the protocol.
  • Subject is mentally or legally incapacitated.
  • Subjects who are kept due to regulatory or juridical order in an institution.
  • Subjects who are in military service.
  • History of sensitivity to heparin or heparin-induced thrombocytopenia.
  • Subjects who have asthma or a history of asthma.
  • 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)).
  • 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.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • GSK Investigational Site

    Berlin, 14050

Other trials in Germany

About this study

Official title: A Randomised, Double-blind, Placebo-controlled, Dose Ascending,3-way Crossover Study to Assess the Pharmacokinetics, Safety Andtolerability of Repeat Inhaled Doses of Nebulised GW870086X Inhealthy Adult Male Volunteers.

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.

Read the detailed description

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
Asthma
Being tested
GW870086X, Placebo
Keywords
ACTH stimulation test, Pharmacokinetics, Nebules, Cortisol
Medical subject headings
Asthma

What participants receive

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

  • GW870086XDrug

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

  • PlaceboDrug

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

Study groups in NCT01160003
Study groupRoleWhat they receive
Treatment Period 1Experimental5mg of GW870086X or placebo will be given once daily for 14 days.
Receives: Drug: GW870086X; Drug: Placebo
Treatment Period 2ExperimentalGW870086X (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.
Receives: Drug: GW870086X; Drug: Placebo
Treatment Period 3Experimental8.75mg of GW870086X or placebo will be given once daily for 14 days.
Receives: Drug: GW870086X; Drug: Placebo

What is being measured

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

  1. Plasma concentrations of GW870086X and GW870086X pharmacokinetic parameters (including AUC, Cmax, t1/2 and tmax)

    Measured: 3 months

Secondary outcomes (5)

  1. Adverse Events

    Measured: 3 months

  2. Clinically relevant changes in safety parameters:Clinical laboratory tests (clinical chemistry, haematology, urinalysis), 12-Lead ECG data; including QT, QTc, HR, QRS and RR intervals, Vital signs: systolic and diastolic blood pressure, pulse rate

    Measured: 3 months

  3. Serum cortisol weighted mean over 24 hours

    Measured: 3 months

  4. Urine cortisol excretion over 24 hours

    Measured: 3 months

  5. ACTH stimulation test (Period 3 only)

    Measured: 3 months

Timeline

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

  1. First posted12 Jul 2010 (estimated)
  2. Study start29 Jul 2010
  3. Primary completion5 Nov 2010
  4. Study completion5 Nov 2010

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
Other
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01160003
Sponsor's protocol ID
113209
Acronym
SIG
Status last verified
Jun 2017
First submitted
8 Jul 2010
Last updated
14 Jun 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.

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 Germany.

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 20 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 14 Jun 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 Germany. 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?

Plasma concentrations of GW870086X and GW870086X pharmacokinetic parameters (including AUC, Cmax, t1/2 and tmax) (time frame: 3 months). 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 NCT01160003.

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 14 Jun 2017.

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