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Healthy SubjectsPhase 1NCT03497715

Gamma Scintigraphy Study to Investigate Tablet Disintegration in Healthy Volunteers.

A Phase 1 study testing Ibuprofen lysine, Ibuprofen Sodium and Ibuprofen in people with Healthy Subjects, run by Reckitt Benckiser Healthcare (UK) Limited.

Terminated

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

Official record
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Trial summary

The study will be an adaptive, 2 part, single dose, 5-way crossover gamma scintigraphy study in healthy subjects, to investigate the rate and site of tablet disintegration of various forms of Ibuprofen. Read more about this study

Who is it for?
Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Subjects
What is being tested?
Ibuprofen lysine, Ibuprofen Sodium and Ibuprofen
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
No sites listed yet
Study dates
14 Apr 2015to 30 Jul 2015
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 50 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age: > 18 to < 50 years.
  • Sex: Male.
  • Status: Healthy volunteers.

Who cannot join

  • A history of significant disease of any body-system.
  • Any condition that may currently interfere with the absorption, distribution, metabolism or excretion of drugs.
  • A history of allergy or intolerance (including angio-oedema, urticaria, bronchospasm and rhinitis) related to treatment with ibuprofen or other nonsteroidal anti-inflammatory drugs (NSAIDs) or the excipients of the formulations.
  • A history of peptic or duodenal ulcers or gastro-intestinal bleed or upper gastrointestinal bleed, or other significant gastro-intestinal disorders.
  • A history of frequent dyspepsia, e.g., heartburn or indigestion.
  • A history of migraine.
Show all 21Show fewer
  • A history of psychotic illness, attempted suicide or parasuicide.
  • Current smokers and ex-smokers who have smoked within 6 months.
  • A history of drug abuse (including alcohol).
  • High consumption of stimulating drinks (coffee, tea, cola, energy drinks etc.; total caffeine intake per day above 300 mg (1 cup of coffee equates to 50 mg).
  • Those with positive drugs of abuse screen including alcohol on any occasion throughout the study.
  • Ingestion of a prescribed drug at any time in the 14 days before dosing with study medication (excluding hormonal contraceptives and hormone replacement therapy), or consumption of enzyme inhibitors or inducers during the previous month (such as barbiturates, carbamazepine, erythromycin, phenytoin, etc.).
  • Ingestion of an over-the-counter preparation within 7 days before dosing with study medication, including herbal medications, vitamin/fish oil supplements, ibuprofen and other NSAIDs and paracetamol.
  • Known human immune deficiency virus (HIV) positive status, or a positive viral serology screen.
  • Those unable in the opinion of the Investigator to comply fully with the study requirements.
  • Those who are unwilling to consume gelatin of animal origin.
  • Those previously randomised into this study.
  • Employee at study site.
  • Partner or first degree relative of the investigator
  • Those who have participated in a clinical trial in the previous 12 weeks.
  • Participation in a study in which radioisotopes were administered or in which subjects were exposed to any radiation (e.g. x-rays, handling of radiolabelled materials) other than normal background radiation within the 12 months before the screening visit.

About this study

Official title: A Randomised, Single Dose, 5 Way Crossover, Open-label Adaptive Design, Gamma Scintigraphy Study Comparing the Disintegration Profile of Oral Ibuprofen Lysine 2 x 342 mg, Ibuprofen Sodium 2 x 256 mg, Ibuprofen Liquid Capsules 2 x 200 mg and Two Reference Formulations of Ibuprofen Acid 2 x 200 mg in Healthy Volunteers

The study will be an adaptive, 2 part, single dose, 5-way crossover gamma scintigraphy study in healthy subjects, to investigate the rate and site of tablet disintegration of various forms of Ibuprofen.

Read the detailed description

Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic and anti-pyretic properties. There are now a wide variety of formulations of ibuprofen available on market in which the active ingredient, ibuprofen, is either as the free acid, salt or salt in situ. As a result of differences between these formulations, differences in absorption and time to effectiveness are achieved. Rates of absorption are commonly assessed using pharmacokinetic (PK) studies, where the time taken for therapeutic plasma concentration levels to be reached can be determined, with associated absorption profiles being generated.

Before absorption can occur the product must disintegrate in the stomach and empty into the small intestine. Gamma scintigraphy may be used to assess the disintegration rate (of tablets/capsules/caplets) by acquiring images of the investigational medicinal product (IMP) in vivo. Through the use of radiolabelled dosage forms, it enables the visualisation of key stages preceding absorption, including tablet disintegration and the rate of gastric emptying. The assessment of these stages, which are required prior to absorption in the small intestine, may be useful in gaining an understanding of the differences between the dosage forms. The main purpose of this study is to visualise and determine the rate of disintegration and subsequent availability for absorption of different ibuprofen formulations, by gamma scintigraphy.

The study will be conducted in two parts. Part 1 will be conducted as a pilot phase where each subject will receive all 5 IMPs over 5 treatment visits (one IMP/visit).

The data generated in Part 1 will be assessed and used to determine whether to continue to Part 2 as planned, continue to Part 2 with adaptations or stop the study. Adaptations may involve altering the radiolabelling procedure and/or the gamma scintigraphy procedure and/or associated time-points and/or redefining primary/secondary endpoints and statistical analyses.

Being tested
Ibuprofen lysine, Ibuprofen Sodium, Ibuprofen, Ibuprofen (Nurofen), Ibuprofen (Wockhardt)

What participants receive

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

  • Ibuprofen lysineDrug

    Also called Nurofen Migraine pain

    Test 1

  • Ibuprofen SodiumDrug

    Also called Nurofen Express

    Test 2

  • IbuprofenDrug

    Also called Nurofen Immedia

    Test 3

  • Ibuprofen (Nurofen)Drug

    Also called Nurofen

    Reference 1

  • Ibuprofen (Wockhardt)Drug

    Reference 2

Study groups in NCT03497715
Study groupRoleWhat they receive
Experimental 1ExperimentalTreatment order: Ibuprofen liquid capsules, Ibuprofen sodium, Ibuprofen (Nurofen), Ibuprofen lysine, Ibuprofen (Wockhardt)
Receives: Drug: Ibuprofen lysine; Drug: Ibuprofen Sodium; Drug: Ibuprofen; Drug: Ibuprofen (Nurofen); Drug: Ibuprofen (Wockhardt)
Experimental 2ExperimentalTreatment order: Ibuprofen lysine, Ibuprofen (Wockhardt), Ibuprofen sodium, Ibuprofen (Nurofen), Ibuprofen liquid capsules
Receives: Drug: Ibuprofen lysine; Drug: Ibuprofen Sodium; Drug: Ibuprofen; Drug: Ibuprofen (Nurofen); Drug: Ibuprofen (Wockhardt)
Experimental 3ExperimentalTreatment order: Ibuprofen liquid capsules, Ibuprofen (Nurofen)1, Ibuprofen sodium, Ibuprofen (Wockhardt), Ibuprofen lysine
Receives: Drug: Ibuprofen lysine; Drug: Ibuprofen Sodium; Drug: Ibuprofen; Drug: Ibuprofen (Nurofen); Drug: Ibuprofen (Wockhardt)
Experimental 4ExperimentalTreatment order: Ibuprofen (Wockhardt), Ibuprofen (Nurofen), Ibuprofen lysine, Ibuprofen liquid capsules, Ibuprofen sodium
Receives: Drug: Ibuprofen lysine; Drug: Ibuprofen Sodium; Drug: Ibuprofen; Drug: Ibuprofen (Nurofen); Drug: Ibuprofen (Wockhardt)

What is being measured

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

  1. Radioactive counts

    radioactivity counts as determined by gamma scintigraphy imaging

    Measured: 3 hours

Timeline

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

  1. First posted13 Apr 2018
  2. Study start14 Apr 2015
  3. Primary completion30 Jul 2015
  4. Study completion30 Jul 2015

Why it stopped: On completion of part 1 it was felt that there would be no benefit in completing part 2

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
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03497715
Sponsor's protocol ID
NL1401
Status last verified
Mar 2018
First submitted
19 Mar 2018
Last updated
13 Apr 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ibuprofen lysine, Ibuprofen Sodium and Ibuprofen in people with Healthy Subjects, run by Reckitt Benckiser Healthcare (UK) Limited.

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 3 inclusion and 21 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 13 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

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: On completion of part 1 it was felt that there would be no benefit in completing part 2). 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?

Radioactive counts (time frame: 3 hours). 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 NCT03497715.

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 13 Apr 2018.

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