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Idiopathic Pulmonary FibrosisPhase 1NCT02052297

A Validation and Dosimetry Study of GSK2634673F PET Ligand

A Phase 1 study testing GSK2634673F in people with Idiopathic Pulmonary Fibrosis, run by GlaxoSmithKline at 2 sites in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a methodology study to examine the quantification of GSK2634673F binding in humans, with the aim of characterising a robust, non-invasive method to quantify the specific binding signal for the alpha(V)beta6 protein in human tissues. Read more about this study

Who is it for?
Ages 45 years and olderHealthy volunteers can take part
Conditions the study is for
Idiopathic Pulmonary Fibrosis
What is being tested?
GSK2634673F
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
2 sitesUnited Kingdom
Study dates
24 Jan 2014to 21 Apr 2016
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 45 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subject is ambulant and capable of attending a PET scan visit as an outpatient.
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form and an understanding of spoken English.
  • A female subject is eligible to participate if she is of non-childbearing potential defined as pre-menopausal female with a documented tubal ligation or hysterectomy [for this definition, "documented" refers to the outcome of the investigator's/designee's review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records]; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) 21.7 - 153.0 International units per liter (IU/L) and oestradiol <110 picomole per liter (pmol/L) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods listed in the protocol if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.
  • Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from after Scan 1 and until the follow-up contact.
  • Male subjects >=45 years and female subjects >=55 years at the time of signing the informed consent.
  • Adequate collateral flow to the radial and ulnar arteries in both hands as determined by an Allen's test.
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  • Body weight >=50 kilogram (kg) and body mass index (BMI) within the range 19.0 - 31.0 kg/meter (m)^2 (inclusive).
  • Additional Inclusion Criteria for Part A and B (healthy subjects):
  • Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history (including family), physical examination, vital signs, previous laboratory studies, and other tests.
  • Additional Inclusion Criteria for Part C (IPF subjects):
  • A diagnosis of IPF according to the consensus criteria.

Who cannot join

  • Criteria Based Upon Medical Histories
  • Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • History of or suffers from claustrophobia or subject feels unable to lie flat and still on their back for a period of up to 4 hours in the PET/CT scanner (note that periodic rest intervals will be allowed as required).
  • Previous inclusion in a research and/or medical protocol involving nuclear medicine, PET or radiological investigations or occupational exposure resulting in radiation exposure greater than 10 mSv over the past 3 years or greater than 10 mSv in a single year including the proposed study. Clinical exposure from which the subject receives a direct benefit is not included in these calculations.
  • Criteria Based Upon Diagnostic Assessments
  • A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
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  • A positive test for human immunodeficiency virus (HIV) antibody.
  • Clinically significant anaemia- Hemoglobin <11 grams per deciliter.
  • Clinically significant thrombocytopenia or an abnormal blood coagulation profile.
  • Other Criteria
  • Previous or current exposure to animals that may harbour the foot and mouth disease virus (FMDV2).
  • Previous long term (>= 3 months) residence in a country where FMDV2 is endemic (such as certain areas of Africa, Asia and South America).
  • Where participation in the study would result in donation of blood or blood products in excess of 500 milliliter (mL) within a 56 day period.

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

  • GSK Investigational Site

    London, NW10 7EW

  • GSK Investigational Site

    London, W12 0NN

Other trials in United Kingdom

About this study

Official title: Validation and Dosimetry Study of [18F]-FBA-A20FMDV2 PET Ligand for Alpha(V)beta6 in Healthy Subjects and in the Lungs of Idiopathic Pulmonary Fibrosis (IPF) Subjects (PETAL Study)

This is a methodology study to examine the quantification of GSK2634673F binding in humans, with the aim of characterising a robust, non-invasive method to quantify the specific binding signal for the alpha(V)beta6 protein in human tissues. This will be the first time that this micro-dose ligand is administered to humans. The study will consist of three parts; Part A, Part B and Part C. Healthy subjects will be recruited into Parts A and B of the study in order to gain experience with the GSK2634673F positron emission tomography (PET) ligand and to optimise the scanning procedures prior to administration to IPF patients in Part C.

Being tested
GSK2634673F
Keywords
Idiopathic Pulmonary Fibrosis (IPF), dosimetry, Positron Emission Tomograph (PET)
Medical subject headings
Idiopathic Pulmonary Fibrosis

What participants receive

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

  • GSK2634673FOther

    Also called PET radiolabelled molecule

    GSK2634673F is a synthetic peptide derived from the foot and mouth disease virus (FMDV2). GSK2634673F will be injected into a cubital or forearm vein intravenously and emission data acquired for up to 240 minutes. This radioactive ligand binds potently and specifically to the integrin alpha(V)beta6.

Study groups in NCT02052297
Study groupRoleWhat they receive
Part AOtherIn Part A, up to 6 healthy subjects will be enrolled in order to determine the human radiodosimetry following administration of the PET radioligand.
Receives: Other: GSK2634673F
Part BOtherIn Part B, up to 8 healthy subjects will be recruited to provide sufficient PET data to quantify the uptake and distribution of GSK2634673F in healthy subjects.
Receives: Other: GSK2634673F
Part COtherIn Part C, up to 20 IPF subjects will be recruited to provide sufficient PET data to quantify the uptake and distribution of GSK2634673F in IPF subjects and, if appropriate, potentially quantify the test/re-test variability.
Receives: Other: GSK2634673F

What is being measured

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

  1. Part A: Radiation effective dose (Millisievert [mSV]/Megabecquerel [MBq]) for whole body

    Radiodosimetry will be determined following administration of the GSK2634673F PET radioligand

    Measured: 1 day

  2. Part B and C: Uptake and distribution of GSK2634673F in organs of interest (volume of distribution [VT], binding potential [BP] and/or standardised uptake values [SUV])

    The utility of GSK2634673F to quantify integrin alpha(V)beta6 availability in healthy subjects (Part B) and in the lungs of patients with IPF (Part C) will be determined.

    Measured: Up to 2 weeks

Secondary outcomes (5)

  1. Part B: Critical time for scanning post-administration of GSK2634673F

    Scanning will be started at the same time as injection of the radioligand and data will be collected for up to 240 minutes

    Measured: 1 day

  2. Part B: Analysis method to quantify integrin alpha(V)beta6 expression from the healthy subject data for use in Part C

    Measured: 1 day

  3. Part C: Qualitative assessment of the relationship between the distribution of fibrosis in the lungs from IPF patients and the uptake of GSK2634673F

    High Resolution Computerised Tomography scan (HRCT) of the lungs will be done to allow the potential establishment of areas of fibrosis in the patient lung

    Measured: Up to 2 weeks

  4. Part C: Comparison of VT, BP and/or SUV in IPF versus healthy lungs

    Measured: Up to 2 weeks

  5. Part C: Test/re-test variability of VT, BP and/or SUV

    IPF patients may receive a repeat GSK2634673F PET/Computed tomography (CT) in order to determine the variability in αvβ6 expression over time and allow test/re-test variability to be assessed

    Measured: Up to 2 weeks

Timeline

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

  1. First posted3 Feb 2014 (estimated)
  2. Study start24 Jan 2014
  3. Primary completion21 Apr 2016
  4. Study completion21 Apr 2016

Why it stopped: The study was terminated due to challenges recruiting subjects with fibrotic interstitial lung disease associated with a connective tissue disease for Part D

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
Basic science
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02052297
Sponsor's protocol ID
116235
Status last verified
Jun 2018
First submitted
16 Jan 2014
Last updated
25 Jun 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK2634673F in people with Idiopathic Pulmonary Fibrosis, run by GlaxoSmithKline at 2 sites 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 11 inclusion and 13 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: stopped early, as of the sponsor's last update on 25 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 was stopped early (reason given: The study was terminated due to challenges recruiting subjects with fibrotic interstitial lung disease associated with a connective tissue disease for Part D). Results are not available in the source record.

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?

Part A: Radiation effective dose (Millisievert [mSV]/Megabecquerel [MBq]) for whole body (time frame: 1 day). The study lists 2 primary outcomes in all. 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 NCT02052297.

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 25 Jun 2018.

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