ClinicalTrials.gg
CompletedNCT03328117Updated Jul 13, 2018

A Study to Investigate the Effects of Imatinib on Pulmonary Vascular Dysfunction in a Human Model of Lung Injury

A Phase 1 interventional study of Imatinib and Placebo oral capsule in Acute Lung Injury, sponsored by Exvastat Ltd.. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-13.

Sponsored by Exvastat Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
47
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 18 studies in Acute Lung Injury with a site in United Kingdom — 1 open to participants now, 1 under way, none of them phase 3. Acute Lung Injury · United Kingdom.

Enrollment
10th of 14
47 · median 53
Started
2017
with 1 other
Phase 1
5 of 18
none open now
Registered
11th of 18
by date
Lead sponsor
1 of 18
Exvastat Ltd.

Among the 18 studies in Acute Lung Injury with a site in United Kingdom, this one is the 10th largest by enrollment of the 14 interventional ones that give a count, is one of 2 that started in 2017, is one of 5 in phase 1, and was the 11th registered.

Acute Lung Injury

382 studies on the registry are indexed under Acute Lung Injury; 73 are open to participants now.

Browse Acute Lung Injury studies →

Open to participants now

1 of the 18 studies in Acute Lung Injury with a site in United Kingdom is open now. Recruiting first, the newest first:

A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →

Who these studies take

Of the 45 Acute Lung Injury studies recruiting now, 25 (56%) set no upper age limit and 8 (18%) stop at 75 or younger; 6 take children under 18; 7 take healthy volunteers.

This study: 18 Years to 55 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 18 studies in Acute Lung Injury with a site in United Kingdom, or all of them as a file.
02

Study summary

The study is a randomized, double-blind, placebo-controlled clinical study of imatinib (as mesilate) in healthy subjects exposed inhaled lipopolysaccharide. During the study, eight oral doses of imatinib, or placebo, will each be taken 12 hours apart, before subjects are exposed to nebulized lipopolysaccharide (LPS). Four hours after LPS exposure, a bronchoalveolar lavage (BAL) will be undertaken, and BAL fluid (BALF collected. Once study assessments are completed, a follow-up visit will be conducted approximately 7 days after the last dose of imatinib.

The primary objective of the study is to investigate the effect of imatinib on LPS-induced pulmonary vascular dysfunction. The primary endpoints of this study are:

  1. Change in the number of neutrophils in BALF 6 hours after the LPS challenge in subjects exposed to imatinib compared with placebo.
  2. Change in concentration of total protein in BALF 6 hours after the LPS challenge in subjects exposed to imatinib compared with placebo
03

Conditions studied

  • Acute Lung Injury

Browse trials for

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Are able and willing to provide written to participate in this clinical study.
  2. Healthy males and females, between 18 and 55 years old (both inclusive) at the screening visit.
  3. Male subjects must practice an acceptable method from the time of first IMP administration until 6 weeks after the follow-up visit.
  4. Female subjects must either be:

    1. Of non-:
    2. Or if of childbearing potential, must practice an acceptable contraceptive method from 4 weeks before the first IMP administration until 6 weeks after the follow-up visit.
  5. Good general health as ascertained by detailed medical history and physical examination at the screening visit.
  6. ≥18.0 and ≤30 kg/m2 at the screening visit.
  7. No abnormalities in the 12-lead as per the Investigator's judgement at the screening visit
  8. No clinically relevant abnormalities in results of clinical laboratory tests as per the Investigator's judgement at the screening visit.
  9. Normal spirometry ( ≥ 85% of predicted, FEV1/FVC ratio ≥ 70%) at the screening visit.
  10. Non-smokers or no history of smoking (including e-cigarettes and other forms of vaporizing/inhalation) in the last 6 months prior to the screening visit.
  11. Subjects must be able to communicate well with the Investigator/designee.

Exclusion criteria

Exclusion Criteria:

  1. History of to the IMP or any of the or to medicinal products with similar chemical structures.
  2. Presence of any acute or chronic disease which could interfere with the subject safety during the study, expose the subject to undue risk, limit the biological sampling, interfere with the absorption of the product (or interfere with the study objectives.
  3. Any history of previous respiratory, hematological or malignant disease, including childhood asthma.
  4. Any history of chronic renal, cardiac (previous myocardial infarction, diagnosis of cardiac failure or cardiac rhythm disturbances such as atrial fibrillation) or hepatic impairment.
  5. Current evidence of ongoing or acute infection, history of repeated or chronic significant infections, or history of serious infection within 3 months of randomization. Acute infection is defined as a history of febrile illness (> 38°C), or 2 or more of the following symptoms within the last 7 days prior to the screening visit or Day 1: cough, sore throat, runny nose, sneezing, limb/joint pain, headache or vomiting/diarrhea.
  6. Any condition that in the opinion of the Investigator will require regular concomitant medication including herbal products, or predicted need of any concomitant medication during the study.
  7. Intake of any prescription and over-the-counter medication (except paracetamol, hormonal and hormonal replacement therapy) including herbal and dietary supplements (including St John's Wort), vitamins and minerals, within 7 days or 5 half-lives (whichever is longer) prior to the first dose of IMP.
  8. Systolic blood pressure \< 90 mmHg or > 140 mmHg, or diastolic blood pressure \< 50 mmHg or > 90 mmHg after 5 minutes in the supine position at the screening visit.
  9. Positive test results for surface antigen (HBsAg), virus antibodies (HCVAb) or (HIV)-1 and/or -2 antibodies at the screening visit.
  10. Excessive use of caffeine-containing beverages exceeding 500 mg caffeine/day (5 cups of coffee) or intake of food or drinks containing xantine (e.g., caffeine) within 24 hours prior to the screening visit or Day 1.
  11. Positive urine cotinine test at the screening visit or Day 1, or the inability to stop using nicotine-containing products during the clinical study.
  12. History or presence of drug addiction (positive urine drug screen at the screening visit or Day 1).
  13. History of regular alcohol consumption within 6 months of the screening visit defined as an average weekly intake of > 21 units (or an average daily intake of > 3 units) for males or an average weekly intake of > 14 units (or an average daily intake > 2 units) for females.
  14. Positive urine alcohol test at the screening visit or Day 1, or the inability to refrain from the use of alcohol during the clinical study.
  15. Intake of any food or any drinks containing grapefruit, Chinese grapefruit (pomelo), Seville orange (including marmalade) or quinine-containing products (e.g., tonic water, bitter lemon) from 7 days prior to Day 1.
  16. Blood component or plasma donation within 3 months prior to the first dose of IMP.
  17. Participation in another study with an experimental drug within 3 months before the first dose of IMP. Exclusion period starts from last IMP dosed in previous study to first dose of IMP.
  18. Any psychological, emotional problems, any disorders or resultant therapy that is likely to invalidate , or limited the ability of the subject to comply with the protocol requirements.
  19. Subject is mentally or legally incapacitated.
  20. A pregnant woman or a nursing mother.
  21. Unlikely to comply with the protocol requirements, instructions and study-related restrictions; e.g., uncooperative attitude and improbability of completing the clinical study.
  22. Subjects who, in the opinion of the Investigator, are considered unsuitable for any other reason.
Terms in these criteria, in plain language(13)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
47 participants (actual)

Study arms

  • Active comparator
    Intervention

    Drug: Imatinib

  • Placebo comparator
    Placebo

    Drug: Placebo oral capsule

Interventions

  • Over-encapsulated 100 mg imatinib mesilate tablets

  • DrugPlacebo oral capsule

    Matching placebo oral capsule

06

What researchers measure

Primary outcomes

  1. Change in the number of neutrophils in bronchoalveolar lavage fluid in subjects exposed to imatinib compared with placebo

    Change in the number of neutrophils in bronchoalveolar lavage fluid in subjects exposed to imatinib compared with placebo

    Time frame: 6 hours after lipopolysaccharide inhalation

  2. Change in concentration of total protein in bronchoalveolar lavage fluid in subjects exposed to imatinib compared with placebo

    Change in concentration of total protein in bronchoalveolar lavage fluid in subjects exposed to imatinib compared with placebo

    Time frame: 6 hours after the LPS challenge

07

Study locations

1 site
  • PAREXEL Early Phase Clinical Unit
    London, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2017 to primary completion in Mar 2018, 3 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 24, 2017
First posted
Nov 1, 2017
StartActual
Nov 13, 2017
Primary completionActual
Mar 5, 2018
CompletionActual
Mar 5, 2018
Last update
Jul 13, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03328117
Lead sponsor
Exvastat Ltd.
Collaborators
Parexel
Responsible party
Sponsor
First posted
Nov 1, 2017
Start date
Nov 13, 2017
Primary completion
Mar 5, 2018
Completion
Mar 5, 2018
Last update
Jul 13, 2018

Study contacts

Muna Albayaty, MBBCh
principal investigator · Parexel

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drug tested here: Imatinib

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