Healthy VolunteersPhase 1NCT02206854
Bioavailability, Pharmacokinetics and Tissue Distribution of R-flurbiprofen Capsules in Healthy Subjects
A Phase 1 study testing R-flurbiprofen in people with Healthy Volunteers, run by Gerd Geisslinger at 1 site in Germany.
Trial summary
For previous clinical trials, R-flurbiprofen has been prepared in tablet form. In this study R-flurbiprofen, will be available as gelatine capsules. This study aims to show the bioavailability of R-flurbiprofen when administered in gelatine capsules. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- R-flurbiprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2014to Sep 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects aged 18 to 65 years
- Body mass index (BMI) between 18.5 und 30 kg/m2
- Subject is judged to be in good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests
- Subject has no evidence of clinically significant abnormality on echocardiogram (ECG) performed at screening visit and/or prior to administration of the study drug
- Non-Smoker
- Subjects providing informed consent
Who cannot join
- Subjects with known hypersensitivity to study medication
- Subjects who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)
- Subjects with a history of peptic ulcer disease and/or gastrointestinal bleeding
- Pregnant women (pregnancy rapid assay required for women with childbearing potential), women currently breast-feeding, or with the intention to breast-feed
- History or evidence of active malignancy within the 24 months prior to entry.
- Subject has a history of fainting during blood draws.
Show all 15Show fewer
- Subject has had major surgery, donated or lost 1 unit of blood (approximately 500 ml) in the last 4 weeks
- Subject is currently a regular user (including "recreational use) of illicit drugs or has a history of drug (including alcohol) abuse within approximately 2 years.
- Active or history of drug abuse,
- Chronic or acute renal, hepatic or metabolic disorder
- Participation in a clinical study within 30 days prior to screening
- Subjects with immunodeficiencies such as established acquired immunodeficiency syndrome.
- Subject is unable to refrain from or anticipates the use of any medication, (including prescription and non-prescription drugs or herbal remedies (such as St. John's Wort) beginning approximately 2 weeks (or 5 half-lives) prior to administration of the initial dose of study drug until the follow-up visit.
- Subject has a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
- There is any concern of the investigator regarding the safe participation of the subject in the study or for any other reason, the investigator considers the subject inappropriate for participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
For previous clinical trials, R-flurbiprofen has been prepared in tablet form. In this study R-flurbiprofen, will be available as gelatine capsules.
This study aims to show the bioavailability of R-flurbiprofen when administered in gelatine capsules. The serum availability will be determined by analysis of pharmakokinetic (pK)-blood samples at different time points. To assess the safety of the administered capsules adverse events will be documented.
Analysis of lipid signaling molecules in plasma will be done to assess the role of this molecules as variable for therapeutic effects.
- Conditions
- Healthy Volunteers
- Being tested
- R-flurbiprofen
- Keywords
- Pharmakokinetic, capsules, R-Flurbiprofen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R-flurbiprofenDrug
Also called Tarenflurbil
200 mg gelatine capsule once orally
| Study group | Role | What they receive |
|---|---|---|
| R-flurbiprofen | Experimental | 200 mg R-flurbiprofen in gelatine capsules once Receives: Drug: R-flurbiprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC)
assessment of concentration at baseline (0), 30, 60, 90, 120 and 150 minutes and 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration of study medication
Measured: prior to administration, 30, 60, 90, 120 and 150 minutes and 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration
Time to maximum concentration (Tmax; hours)
Measured: prior to administration, 30, 60, 90, 120 and 150 minutes and 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration
Maximum concentration (Cmax).
Measured: prior to administration, 30, 60, 90, 120 and 150 minutes and 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration
Terminal elimination half-life (t1/2)
Measured: prior to administration, 30, 60, 90, 120 and 150 minutes and 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration
Secondary outcomes (2)
Number of volunteers with serious and Non serious adverse events
Number and type of Adverse Events (AEs) and Serious Adverse Events (SAEs) will be documented at V1 (predose and after administration) and at V3 (follow-up visit 8 to 15 days after administration of study medication)
Measured: Up to day 15
Analysis of plasma lipid profile
parallel to pK-Analysis plasma lipid profile will be assessed
Measured: prior and 30, 60, 90, 120 and 150 minutes and 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gerd Geisslinger
- Sponsor type
- University, hospital or other
- Collaborators
- Fraunhofer Institute for Translational Medicine and Pharmacology ITMP
- Responsible party
- Sponsor-investigator, Gerd Geisslinger, Goethe University
- Investigators
- Gerd Geisslinger, Prof MD, Principal investigator, Goethe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02206854
- Sponsor's protocol ID
- FLIP0112
- Other IDs
- 2012-001425-27
- Status last verified
- Sep 2015
- First submitted
- 31 Jul 2014
- Last updated
- 11 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability, Pharmacokinetics and Tissue Distribution of R-flurbiprofen Capsules in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02206854
- Acronym / sponsor ID
- FLIP0112
- Conditions
- Healthy Volunteers
- Keywords
- Pharmakokinetic, capsules, R-Flurbiprofen
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Gerd GeisslingerUniversity, hospital or other
- Collaborators
- Fraunhofer Institute for Translational Medicine and Pharmacology ITMP
- Study start
- Jun 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 1 Aug 2014 (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.
For previous clinical trials, R-flurbiprofen has been prepared in tablet form. In this study R-flurbiprofen, will be available as gelatine capsules.
This study aims to show the bioavailability of R-flurbiprofen when administered in gelatine capsules. The serum availability will be determined by analysis of pharmakokinetic (pK)-blood samples at different time points. To assess the safety of the administered capsules adverse events will be documented.
Analysis of lipid signaling molecules in plasma will be done to assess the role of this molecules as variable for therapeutic effects.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| R-flurbiprofen | Experimental | Drug: R-flurbiprofen200 mg R-flurbiprofen in gelatine capsules once |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy subjects aged 18 to 65 years
- Body mass index (BMI) between 18.5 und 30 kg/m2
- Subject is judged to be in good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests
- Subject has no evidence of clinically significant abnormality on echocardiogram (ECG) performed at screening visit and/or prior to administration of the study drug
- Non-Smoker
Key exclusion criteria (15 listed)
- Subjects with known hypersensitivity to study medication
- Subjects who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)
- Subjects with a history of peptic ulcer disease and/or gastrointestinal bleeding
- Pregnant women (pregnancy rapid assay required for women with childbearing potential), women currently breast-feeding, or with the intention to breast-feed
- History or evidence of active malignancy within the 24 months prior to entry.
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 |
|---|---|---|
| R-flurbiprofenAlso: Tarenflurbil200 mg gelatine capsule once orally | Drug | R-flurbiprofen |
Primary outcome
Area under the curve (AUC)
Time frame: prior to administration, 30, 60, 90, 120 and 150 minutes and 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration
assessment of concentration at baseline (0), 30, 60, 90, 120 and 150 minutes and 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration of study medication
Time to maximum concentration (Tmax; hours)
Time frame: prior to administration, 30, 60, 90, 120 and 150 minutes and 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration
Maximum concentration (Cmax).
Time frame: prior to administration, 30, 60, 90, 120 and 150 minutes and 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration
Terminal elimination half-life (t1/2)
Time frame: prior to administration, 30, 60, 90, 120 and 150 minutes and 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration
2 secondary outcomes
Number of volunteers with serious and Non serious adverse events
Time frame: Up to day 15
Analysis of plasma lipid profile
Time frame: prior and 30, 60, 90, 120 and 150 minutes and 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration
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 11 Sep 2015.
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Screening Protocol
Pain
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.
Gerd Geisslinger, Prof MD principal investigator
Goethe University
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 R-flurbiprofen in people with Healthy Volunteers, run by Gerd Geisslinger at 1 site in Germany.
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 6 inclusion and 15 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 11 Sep 2015. 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 Germany. 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?
Area under the curve (AUC) (time frame: prior to administration, 30, 60, 90, 120 and 150 minutes and 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration). The study lists 4 primary outcomes in all. 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 11 Sep 2015.