Moderate PainPhase 1NCT03225352
A Study to Assess Disintegration of the New Aspirin Disintegrating Tablets
A Phase 1 study testing 500 mg acetylsalicylic acid (Aspirin, BAYE4465), 1000 mg acetylsalicylic acid (Aspirin, BAYE4465) and 400 mg ibuprofen(Nurofen) in people with Moderate Pain, run by Bayer at 1 site in United Kingdom.
Trial summary
The aim of this study is to assess disintegration of the new Aspirin disintegrating tablets 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
- Moderate Pain
- What is being tested?
- 500 mg acetylsalicylic acid (Aspirin, BAYE4465), 1000 mg acetylsalicylic acid (Aspirin, BAYE4465) and 400 mg ibuprofen(Nurofen)
- 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
- 7 Aug 2017to 16 Oct 2017
- 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
- Healthy male volunteers aged 18 to 65 years included
- Verified diagnosis of "healthy"
- Non-smokers or passive smokers
- BMI in the range of 18.5 to 30 kg/m2
- Subject has given written informed consent to participate in the trial prior to admission to the trial
Who cannot join
- Blood donation within the last 90 days prior to planned randomization
- Any previous medication within 10 days before the planned administration of the radiolabelled Investigational Medicinal Product (rIMP) which, in the opinion of the physician responsible, will interfere with the study procedures or compromise safety
- Subject has any non-removable metal objects such as metal plates, screws etc. in their chest or abdominal area which, in the opinion of the physician responsible, could affect the study conduct.
- Vegetarian
- Subjects for whom participation in this study will exceed the limits of total radiation exposure allowed in any 12 month period (5 Millisievert), or will exceed 10 Millisievert over any three year period
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Bio-Images Research Ltd
Glasgow, Glasgow City, G4 0SF
About this study
Official title: An Open Label, Randomized, Four-Way Crossover Trial to Assess the Disintegration, Gastric Emptying and Pharmacokinetic Parameters of a New Disintegrating Acetylsalicylic Acid 500 mg, 1000 mg Tablet Formulation and 2 Different Ibuprofen Tablets in Fasted Healthy Male Subjects
The aim of this study is to assess disintegration of the new Aspirin disintegrating tablets
- Conditions
- Moderate Pain
- Being tested
- 500 mg acetylsalicylic acid (Aspirin, BAYE4465), 1000 mg acetylsalicylic acid (Aspirin, BAYE4465), 400 mg ibuprofen(Nurofen), 400 mg ibuprofen (Dolormin Extra)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
500 mg acetylsalicylic acid (Aspirin, BAYE4465)Drug
Single intake of 1 tablet, 500mg
1000 mg acetylsalicylic acid (Aspirin, BAYE4465)Drug
Single intake of 1 tablet, 1000mg
400 mg ibuprofen(Nurofen)Drug
Single intake of 1 tablet, 400mg
400 mg ibuprofen (Dolormin Extra)Drug
Single intake of 1 tablet, 400mg
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: starting with BAYE4465 500 mg | Experimental | Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design Receives: Drug: 500 mg acetylsalicylic acid (Aspirin, BAYE4465); Drug: 1000 mg acetylsalicylic acid (Aspirin, BAYE4465); Drug: 400 mg ibuprofen(Nurofen); Drug: 400 mg ibuprofen (Dolormin Extra) |
| Sequence 2: starting with BAYE4465 1000 mg | Experimental | Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design Receives: Drug: 500 mg acetylsalicylic acid (Aspirin, BAYE4465); Drug: 1000 mg acetylsalicylic acid (Aspirin, BAYE4465); Drug: 400 mg ibuprofen(Nurofen); Drug: 400 mg ibuprofen (Dolormin Extra) |
| Sequence 3: starting with Nurofen | Experimental | Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design Receives: Drug: 500 mg acetylsalicylic acid (Aspirin, BAYE4465); Drug: 1000 mg acetylsalicylic acid (Aspirin, BAYE4465); Drug: 400 mg ibuprofen(Nurofen); Drug: 400 mg ibuprofen (Dolormin Extra) |
| Sequence 4: starting with Dolormin Extra | Experimental | Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design Receives: Drug: 500 mg acetylsalicylic acid (Aspirin, BAYE4465); Drug: 1000 mg acetylsalicylic acid (Aspirin, BAYE4465); Drug: 400 mg ibuprofen(Nurofen); Drug: 400 mg ibuprofen (Dolormin Extra) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete tablet disintegration
The tablet is radiolabeled. Scintigraphy images of the abdominal area will be taken It is time until an image with no definable hot spot remaining is identified
Measured: Up to 4 hours
Secondary outcomes (15)
Gastric empty time, if applicable
Gastric emptying time will be calculated by a qualified assessor based on the scintigraphy images
Measured: Up to 4 hours
Time of colon arrival, if applicable
Time of colon arrival will be calculated by a qualified assessor based on the scintigraphy images
Measured: Up to 4 hours
Small intestine transit time, if applicable
Small intestine transit time will be calculated by a qualified assessor based on the scintigraphy images
Measured: Up to 4 hours
Time of onset of release of radiolabel
Time of onset of release of radiolabel will be calculated by a qualified assessor based on the scintigraphy images
Measured: Up to 4 hours
Site of onset of release of radiolabel
Site of onset of release of radiolabel will be determined by a qualified assessor based on the scintigraphy images
Measured: Up to 4 hours
Site of completion of release of radiolabel
Site of completion of release of radiolabel will be determined by a qualified assessor based on the scintigraphy images
Measured: Up to 4 hours
Disintegration rate of the tablet estimated from the radioactivity remaining
Disintegration rate of the tablet estimated from the radioactivity rem will be calculated by a qualified assessor based on the scintigraphy images
Measured: Up to 4 hours
Time of 50% disintegration of the tablet estimated from the radioactivity remaining
Time of 50% disintegration of the tablet estimated from the radioactivity remaining will be calculated by a qualified assessor based on the scintigraphy images
Measured: Up to 4 hours
Gastric emptying kinetics of dispersed radioactive material (t50% and t90%)
Gastric emptying kinetics of dispersed radioactive material (t50% and t90%) will be calculated by a qualified assessor based on the scintigraphy images
Measured: Up to 4 hours
AUC0-t
Area under the plasma concentration vs time curve from zero to the last data point
Measured: Prior to dosing (between 60-15 min), and 5, 9, 13, 18, 23, 28, 33, 38, 48, 58, 68, 78, 88, 118, 178 and 238 min post-dose
Cmax
Maximum drug concentration in plasma after single dose administration
Measured: Prior to dosing (between 60-15 min), and 5, 9, 13, 18, 23, 28, 33, 38, 48, 58, 68, 78, 88, 118, 178 and 238 min post-dose
AUC0-infinity
Area under the plasma concentration vs time curve from zero to infinity
Measured: Prior to dosing (between 60-15 min), and 5, 9, 13, 18, 23, 28, 33, 38, 48, 58, 68, 78, 88, 118, 178 and 238 min post-dose
t1/2
Half-life associated with the terminal slope
Measured: Prior to dosing (between 60-15 min), and 5, 9, 13, 18, 23, 28, 33, 38, 48, 58, 68, 78, 88, 118, 178 and 238 min post-dose
tmax
Time to reach maximum drug concentration in the measured
Measured: Prior to dosing (between 60-15 min), and 5, 9, 13, 18, 23, 28, 33, 38, 48, 58, 68, 78, 88, 118, 178 and 238 min post-dose
Cmax/AUC0-infinity
Measured: Prior to dosing (between 60-15 min), and 5, 9, 13, 18, 23, 28, 33, 38, 48, 58, 68, 78, 88, 118, 178 and 238 min post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start7 Aug 2017
- Primary completion7 Oct 2017
- Study completion16 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate PainStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03225352
- Sponsor's protocol ID
- 19220
- Other IDs
- 2016-004546-29, 2016
- Status last verified
- Jun 2018
- First submitted
- 16 Jul 2017
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Four-Way Crossover Trial to Assess the Disintegration, Gastric Emptying and Pharmacokinetic Parameters of a New Disintegrating Acetylsalicylic Acid 500 mg, 1000 mg Tablet Formulation and 2 Different Ibuprofen Tablets in Fasted Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03225352
- Acronym / sponsor ID
- 19220
- Conditions
- Moderate Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 7 Aug 2017 (actual)
- Primary completion
- 7 Oct 2017 (actual)
- Study completion
- 16 Oct 2017 (actual)
- First posted
- 21 Jul 2017 (actual)
- 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.
The aim of this study is to assess disintegration of the new Aspirin disintegrating tablets
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: starting with BAYE4465 500 mg | Experimental | Drug: 500 mg acetylsalicylic acid (Aspirin, BAYE4465), Drug: 1000 mg acetylsalicylic acid (Aspirin, BAYE4465), Drug: 400 mg ibuprofen(Nurofen), Drug: 400 mg ibuprofen (Dolormin Extra)Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design |
| Sequence 2: starting with BAYE4465 1000 mg | Experimental | Drug: 500 mg acetylsalicylic acid (Aspirin, BAYE4465), Drug: 1000 mg acetylsalicylic acid (Aspirin, BAYE4465), Drug: 400 mg ibuprofen(Nurofen), Drug: 400 mg ibuprofen (Dolormin Extra)Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design |
| Sequence 3: starting with Nurofen | Experimental | Drug: 500 mg acetylsalicylic acid (Aspirin, BAYE4465), Drug: 1000 mg acetylsalicylic acid (Aspirin, BAYE4465), Drug: 400 mg ibuprofen(Nurofen), Drug: 400 mg ibuprofen (Dolormin Extra)Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design |
| Sequence 4: starting with Dolormin Extra | Experimental | Drug: 500 mg acetylsalicylic acid (Aspirin, BAYE4465), Drug: 1000 mg acetylsalicylic acid (Aspirin, BAYE4465), Drug: 400 mg ibuprofen(Nurofen), Drug: 400 mg ibuprofen (Dolormin Extra)Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy male volunteers aged 18 to 65 years included
- Verified diagnosis of "healthy"
- Non-smokers or passive smokers
- BMI in the range of 18.5 to 30 kg/m2
- Subject has given written informed consent to participate in the trial prior to admission to the trial
Key exclusion criteria (5 listed)
- Blood donation within the last 90 days prior to planned randomization
- Any previous medication within 10 days before the planned administration of the radiolabelled Investigational Medicinal Product (rIMP) which, in the opinion of the physician responsible, will interfere with the study procedures or compromise safety
- Subject has any non-removable metal objects such as metal plates, screws etc. in their chest or abdominal area which, in the opinion of the physician responsible, could affect the study conduct.
- Vegetarian
- Subjects for whom participation in this study will exceed the limits of total radiation exposure allowed in any 12 month period (5 Millisievert), or will exceed 10 Millisievert over any three year period
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 |
|---|---|---|
| 500 mg acetylsalicylic acid (Aspirin, BAYE4465)Single intake of 1 tablet, 500mg | Drug | Sequence 1: starting with BAYE4465 500 mg, Sequence 2: starting with BAYE4465 1000 mg, Sequence 3: starting with Nurofen, Sequence 4: starting with Dolormin Extra |
| 1000 mg acetylsalicylic acid (Aspirin, BAYE4465)Single intake of 1 tablet, 1000mg | Drug | Sequence 1: starting with BAYE4465 500 mg, Sequence 2: starting with BAYE4465 1000 mg, Sequence 3: starting with Nurofen, Sequence 4: starting with Dolormin Extra |
| 400 mg ibuprofen(Nurofen)Single intake of 1 tablet, 400mg | Drug | Sequence 1: starting with BAYE4465 500 mg, Sequence 2: starting with BAYE4465 1000 mg, Sequence 3: starting with Nurofen, Sequence 4: starting with Dolormin Extra |
| 400 mg ibuprofen (Dolormin Extra)Single intake of 1 tablet, 400mg | Drug | Sequence 1: starting with BAYE4465 500 mg, Sequence 2: starting with BAYE4465 1000 mg, Sequence 3: starting with Nurofen, Sequence 4: starting with Dolormin Extra |
Primary outcome
Time to complete tablet disintegration
Time frame: Up to 4 hours
The tablet is radiolabeled. Scintigraphy images of the abdominal area will be taken It is time until an image with no definable hot spot remaining is identified
15 secondary outcomes
Gastric empty time, if applicable
Time frame: Up to 4 hours
Time of colon arrival, if applicable
Time frame: Up to 4 hours
Small intestine transit time, if applicable
Time frame: Up to 4 hours
Time of onset of release of radiolabel
Time frame: Up to 4 hours
Site of onset of release of radiolabel
Time frame: Up to 4 hours
Site of completion of release of radiolabel
Time frame: Up to 4 hours
Disintegration rate of the tablet estimated from the radioactivity remaining
Time frame: Up to 4 hours
Time of 50% disintegration of the tablet estimated from the radioactivity remaining
Time frame: Up to 4 hours
Gastric emptying kinetics of dispersed radioactive material (t50% and t90%)
Time frame: Up to 4 hours
AUC0-t
Time frame: Prior to dosing (between 60-15 min), and 5, 9, 13, 18, 23, 28, 33, 38, 48, 58, 68, 78, 88, 118, 178 and 238 min post-dose
Cmax
Time frame: Prior to dosing (between 60-15 min), and 5, 9, 13, 18, 23, 28, 33, 38, 48, 58, 68, 78, 88, 118, 178 and 238 min post-dose
AUC0-infinity
Time frame: Prior to dosing (between 60-15 min), and 5, 9, 13, 18, 23, 28, 33, 38, 48, 58, 68, 78, 88, 118, 178 and 238 min post-dose
t1/2
Time frame: Prior to dosing (between 60-15 min), and 5, 9, 13, 18, 23, 28, 33, 38, 48, 58, 68, 78, 88, 118, 178 and 238 min post-dose
tmax
Time frame: Prior to dosing (between 60-15 min), and 5, 9, 13, 18, 23, 28, 33, 38, 48, 58, 68, 78, 88, 118, 178 and 238 min post-dose
Cmax/AUC0-infinity
Time frame: Prior to dosing (between 60-15 min), and 5, 9, 13, 18, 23, 28, 33, 38, 48, 58, 68, 78, 88, 118, 178 and 238 min post-dose
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 6 Jun 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 500 mg acetylsalicylic acid (Aspirin, BAYE4465), 1000 mg acetylsalicylic acid (Aspirin, BAYE4465) and 400 mg ibuprofen(Nurofen) in people with Moderate Pain, run by Bayer 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 5 inclusion and 5 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 6 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 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?
Time to complete tablet disintegration (time frame: Up to 4 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 6 Jun 2018.