PainPhase 1NCT02004301
A Study to Investigate Delayed-release Tablets
A Phase 1 study testing Radiolabelled T4 Tablet and Radiolabelled T6 Tablet in people with Pain, run by BDD Pharma Ltd at 1 site in United Kingdom.
Trial summary
This is a single-centre, open-label, non-randomised, two-arm study in 12 healthy male volunteers. This study is designed to correlate the gastrointestinal transit behaviour of delayed-release diclofenac potassium tablets with their pharmacokinetic (PK) absorption profiles. We will be looking at: 1. 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
- Pain
- What is being tested?
- Radiolabelled T4 Tablet and Radiolabelled T6 Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2014to Mar 2014
- 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
- Male 18 to 45 years inclusive. BMI 18.0 to 29.9 kg/m2. Body weight ≥50 kg. Understands and is willing, able and likely to comply with all study procedures and restrictions. Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent.
- Good general health with (in the opinion of the Investigator) no clinically significant and relevant abnormalities of medical history or physical examination.
Who cannot join
- Current or recurrent disease that could affect the study conduct or laboratory assessments.
- Current or relevant previous history of serious, severe or unstable physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the study medication or procedures.
- History of current or relevant previous non self-limiting gastrointestinal disorders, in particular, peptic ulcer disease and/or gastrointestinal bleeding.
- History of hypersensitivity to aspirin or any other NSAID. Currently suffering from disease known to impact gastric emptying, e.g. migraine, insulin-dependent diabetes mellitus.
- Laboratory screening results that suggest an abnormal liver and/or renal function.
- Subject has a screening QTc value of greater than or equal to 450 msec or an ECG that is not suitable for QTc measurements.
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- The physician responsible considers the volunteer unfit for the study. Taken prescribed medication within 14 days prior to the first Assessment Visit which, in the opinion of the physician responsible, will interfere with the study procedures or compromise safety.
- Taken over-the-counter (OTC) medication within 48 hours prior to the first Assessment Visit. Subjects may still be entered into the study if, in the opinion of the physician responsible, the medication will not interfere with the study procedures or compromise safety. The occasional use of paracetamol for pain relief (within its labelled dosage) is permitted but must not be taken within 48 hours of an Assessment Visit.
- Recent history (within the last year) of alcohol or other substance abuse. Average weekly alcohol intake of greater than 21 units. Positive urine drugs of abuse test at screening. Note: At the discretion of the Investigator, the test may be repeated Positive breath alcohol test at screening. Recently discontinued smoking (less than 3 months). Currently a smoker or user of nicotine-containing products. Allergy to a drug, to any component of the dosage form or any other allergy. Vegetarian. Lactose intolerant. Allergy to any of the contents of the standard dinner.
- Participation in another clinical study (inclusive of final post-study examination) or receipt of an investigational drug within the 12 weeks before first screening visit.
- Previous participation in this study. Will result in a participation in more than four studies over a twelve month period.
- An employee of the sponsor, client or study site or members of their immediate family.
- Will exceed the limits of total radiation exposure allowed in any 12 month period (5 mSv), or will exceed 10 mSv over any three year period.
- Intending to father a child in the 3 months following the study or are unwilling to abstain from sexual intercourse with pregnant or lactating women Unwilling to use a condom/spermicide in addition to having their female partner use another form of contraception such as an IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, subdermal implants or a tubal ligation if the woman could become pregnant from the time of the first Assessment Visit until 3 months following the study.
- Donated blood or experienced significant blood loss within 3 months of screening and for the duration of the study.
- Difficulty in accessibility of forearm veins. Any non-removable metal objects in their chest or abdominal.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Bio-Imaging Centre, Basement Medical Block, Within Glasgow Royal Infirmary, 84 Castle Street
Glasgow, G4 0SF
About this study
Official title: A Pilot Pharmacoscintigraphic Clinical Study to Investigate the Behaviour of Delayed-release Tablets Consisting of a Diclofenac Potassium Core Coated With Barrier Granules, in Healthy Volunteers
This is a single-centre, open-label, non-randomised, two-arm study in 12 healthy male volunteers. This study is designed to correlate the gastrointestinal transit behaviour of delayed-release diclofenac potassium tablets with their pharmacokinetic (PK) absorption profiles.
We will be looking at:
- The behaviour of the tablets (when, where and how quickly they break up)
- The gastric emptying time of the tablets (when they leave the stomach)
- The gastrointestinal transit of the tablets (how long they take to travel through the gut)
- Blood levels of the drug (diclofenac)
Read the detailed description
The tablets being tested will contain the drug, diclofenac potassium. Diclofenac potassium is a non-steroidal anti-inflammatory drug (NSAID) taken to reduce inflammation and as an analgesic, reducing pain in certain conditions such as rheumatoid arthritis, gout and post-operative pain.
The 2 treatments are as follows:
Tablet T4: Radiolabelled delayed release diclofenac potassium tablet with time delay of 4 h
Tablet T6: Radiolabelled delayed release diclofenac potassium tablet with time delay of 6 h
In this study we will be using a type of radioactive material (known as technetium-99m) which is routinely used in investigations of this type. A small amount of technetium-99m will be put into each tablet.
Primary Objective A)To assess the site and time of onset and complete release of radiolabel from two delayed-release diclofenac potassium formulations
Secondary Objectives B)To determine gastrointestinal transit parameters of two delayed-release diclofenac potassium formulations C)To determine the plasma concentrations of diclofenac at each PK sampling point post-administration of two delayed-release diclofenac potassium formulations D)To assess and compare between the two delayed-release diclofenac potassium formulations, as a minimum, the following PK parameters: tlag, tmax, Cmax and AUC0-15h
- Conditions
- Pain
- Being tested
- Radiolabelled T4 Tablet, Radiolabelled T6 Tablet
- Keywords
- Formulation behaviour, Drug absorption profile
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiolabelled T4 TabletDrug
Also called Delayed release diclofenac potassium tablet
Radiolabelled T6 TabletDrug
Also called Delayed release diclofenac potassium tablet
| Study group | Role | What they receive |
|---|---|---|
| Radiolabelled T4 Tablet | Experimental | Single dose of delayed release diclofenac potassium (25 mg) tablet with time delay of 4 h radiolabelled with 4 MBq 99mTc Receives: Drug: Radiolabelled T4 Tablet |
| Radiolabelled T6 Tablet | Experimental | Single dose of delayed release diclofenac potassium (25 mg) tablet with time delay of 6 h radiolabelled with 4 MBq 99mTc Receives: Drug: Radiolabelled T6 Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scintigraphic analysis of time and site of onset and complete release of radiolabel
Measured: 15 hours
Secondary outcomes (1)
Pharmacokinetic (PK) absorption profiles and parameters of diclofenac
Measured: 15 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- BDD Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Drug Delivery International Ltd
- Responsible party
- Principal investigator, Howard Stevens, BDD Pharma Ltd
- Investigators
- Howard NE Stevens, PhD, Principal investigator, BDD Pharma Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02004301
- Sponsor's protocol ID
- FM1202A
- Status last verified
- Apr 2014
- First submitted
- 2 Dec 2013
- Last updated
- 10 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Pharmacoscintigraphic Clinical Study to Investigate the Behaviour of Delayed-release Tablets Consisting of a Diclofenac Potassium Core Coated With Barrier Granules, in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02004301
- Acronym / sponsor ID
- FM1202A
- Conditions
- Pain
- Keywords
- Formulation behaviour, Drug absorption profile
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- BDD Pharma LtdIndustry (pharma, biotech, devices)
- Collaborators
- Drug Delivery International Ltd
- Study start
- Jan 2014
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 9 Dec 2013 (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.
This is a single-centre, open-label, non-randomised, two-arm study in 12 healthy male volunteers. This study is designed to correlate the gastrointestinal transit behaviour of delayed-release diclofenac potassium tablets with their pharmacokinetic (PK) absorption profiles.
We will be looking at:
- The behaviour of the tablets (when, where and how quickly they break up)
- The gastric emptying time of the tablets (when they leave the stomach)
- The gastrointestinal transit of the tablets (how long they take to travel through the gut)
- Blood levels of the drug (diclofenac)
Detailed description
The tablets being tested will contain the drug, diclofenac potassium. Diclofenac potassium is a non-steroidal anti-inflammatory drug (NSAID) taken to reduce inflammation and as an analgesic, reducing pain in certain conditions such as rheumatoid arthritis, gout and post-operative pain.
The 2 treatments are as follows:
Tablet T4: Radiolabelled delayed release diclofenac potassium tablet with time delay of 4 h
Tablet T6: Radiolabelled delayed release diclofenac potassium tablet with time delay of 6 h
In this study we will be using a type of radioactive material (known as technetium-99m) which is routinely used in investigations of this type. A small amount of technetium-99m will be put into each tablet.
Primary Objective A)To assess the site and time of onset and complete release of radiolabel from two delayed-release diclofenac potassium formulations
Secondary Objectives B)To determine gastrointestinal transit parameters of two delayed-release diclofenac potassium formulations C)To determine the plasma concentrations of diclofenac at each PK sampling point post-administration of two delayed-release diclofenac potassium formulations D)To assess and compare between the two delayed-release diclofenac potassium formulations, as a minimum, the following PK parameters: tlag, tmax, Cmax and AUC0-15h
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiolabelled T4 Tablet | Experimental | Drug: Radiolabelled T4 TabletSingle dose of delayed release diclofenac potassium (25 mg) tablet with time delay of 4 h radiolabelled with 4 MBq 99mTc |
| Radiolabelled T6 Tablet | Experimental | Drug: Radiolabelled T6 TabletSingle dose of delayed release diclofenac potassium (25 mg) tablet with time delay of 6 h radiolabelled with 4 MBq 99mTc |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male 18 to 45 years inclusive. BMI 18.0 to 29.9 kg/m2. Body weight ≥50 kg. Understands and is willing, able and likely to comply with all study procedures and restrictions. Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent.
- Good general health with (in the opinion of the Investigator) no clinically significant and relevant abnormalities of medical history or physical examination.
Key exclusion criteria (16 listed)
- Current or recurrent disease that could affect the study conduct or laboratory assessments.
- Current or relevant previous history of serious, severe or unstable physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the study medication or procedures.
- History of current or relevant previous non self-limiting gastrointestinal disorders, in particular, peptic ulcer disease and/or gastrointestinal bleeding.
- History of hypersensitivity to aspirin or any other NSAID. Currently suffering from disease known to impact gastric emptying, e.g. migraine, insulin-dependent diabetes mellitus.
- Laboratory screening results that suggest an abnormal liver and/or renal function.
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 |
|---|---|---|
| Radiolabelled T4 TabletAlso: Delayed release diclofenac potassium tablet | Drug | Radiolabelled T4 Tablet |
| Radiolabelled T6 TabletAlso: Delayed release diclofenac potassium tablet | Drug | Radiolabelled T6 Tablet |
Primary outcome
Scintigraphic analysis of time and site of onset and complete release of radiolabel
Time frame: 15 hours
1 secondary outcome
Pharmacokinetic (PK) absorption profiles and parameters of diclofenac
Time frame: 15 hours
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 10 Apr 2014.
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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.
Howard NE Stevens, PhD principal investigator
BDD Pharma Ltd
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 Radiolabelled T4 Tablet and Radiolabelled T6 Tablet in people with Pain, run by BDD Pharma Ltd at 1 site 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 2 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 10 Apr 2014. 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 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 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?
Scintigraphic analysis of time and site of onset and complete release of radiolabel (time frame: 15 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Apr 2014.