PharmacokineticsPhase 1NCT02974361
Impact of Excipients on Pharmacokinetics of OXPzero(TM) Ibuprofen
A Phase 1 study testing Ibuprofen, Ibuprofen Lysine and Ibuprofen-LDH in people with Pharmacokinetics, run by Oxford Pharmascience Ltd at 1 site in United Kingdom.
Trial summary
This study is to help development of a new version of Ibuprofen, called Ibuprofen-LDH. Ibuprofen-LDH will be used as a treatment for muscular pains, headache, fever etc. This new version of ibuprofen is expected to produce fewer stomach/intestine related side effects when compared to many existing marketed… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Ibuprofen, Ibuprofen Lysine and Ibuprofen-LDH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2016to 3 May 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subjects
- BMI 18 - 30 kg/m2
- Willing and able to provide written informed consent
Who cannot join
- Evidence or history of significant renal, hepatic, gastrointestinal, central nervous system, respiratory, cardiovascular, autoimmune or metabolic dysfunction
- Recent or concurrent use of prescription or non-prescription medications, other than contraceptives
- Allergy or sensitivity to NSAIDs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single-dose, Randomised, Crossover Study to Evaluate Changes in the Pharmacokinetics of Ibuprofen From Ibuprofen-LDH Dosed With and Without Release Modifying Excipients in Normal, Healthy, Adult Subjects
This study is to help development of a new version of Ibuprofen, called Ibuprofen-LDH. Ibuprofen-LDH will be used as a treatment for muscular pains, headache, fever etc. This new version of ibuprofen is expected to produce fewer stomach/intestine related side effects when compared to many existing marketed formulations of Ibuprofen.
This study is split into 3 parts. Part A is a 7 way crossover, Part B is a maximum of a 6 way crossover and Part C is a maximum of a 4 way crossover. The size of Parts B \& Part C and allocated interventions will be confirmed after review of data from Parts A and/or B respectively.
Read more
A total of 30 subjects will take part in the study; 10 per study part.
The key objective is to assess the pharmacokinetics properties of Ibuprofen-LDH, with and without a selection of different excipients. The pharmacokinetic properties will include how quickly the drug is absorbed into the bloodstream and also the maximum concentration of drug that reaches the bloodstream.
- Conditions
- Pharmacokinetics
- Being tested
- Ibuprofen, Ibuprofen Lysine, Ibuprofen-LDH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
Ibuprofen LysineDrug
Ibuprofen-LDHDrug
| Study group | Role | What they receive |
|---|---|---|
| Part A Ibuprofen control | Active comparator | Not described Receives: Drug: Ibuprofen |
| Part A Ibuprofen-LDH | Experimental | Not described Receives: Drug: Ibuprofen-LDH |
| Part A Ibuprofen-LDH Excipient Combo 1 | Experimental | Not described Receives: Drug: Ibuprofen-LDH |
| Part A Ibuprofen-LDH Excipient Combo 2 | Experimental | Not described Receives: Drug: Ibuprofen-LDH |
| Part A Ibuprofen-LDH Excipient Combo 3 | Experimental | Not described Receives: Drug: Ibuprofen-LDH |
| Part A Ibuprofen-LDH Excipient Combo 4 | Experimental | Not described Receives: Drug: Ibuprofen-LDH |
| Part A Ibuprofen Lysine | Active comparator | Not described Receives: Drug: Ibuprofen Lysine |
| Part B Ibuprofen | Active comparator | Not described Receives: Drug: Ibuprofen |
| Part B Ibuprofen LDH Excipient Combo 1 | Experimental | Not described Receives: Drug: Ibuprofen-LDH |
| Part B Ibuprofen LDH Excipient Combo 2 | Experimental | Not described Receives: Drug: Ibuprofen-LDH |
| Part B Ibuprofen LDH Excipient Combo 3 | Experimental | Not described Receives: Drug: Ibuprofen-LDH |
| Part B Ibuprofen LDH Excipient Combo 4 | Experimental | Not described Receives: Drug: Ibuprofen-LDH |
| Part C Ibuprofen | Active comparator | Not described Receives: Drug: Ibuprofen |
| Part C Ibuprofen LDH Excipient Combo 1 | Experimental | Not described Receives: Drug: Ibuprofen-LDH |
| Part C Ibuprofen LDH Excipient Combo 2 | Experimental | Not described Receives: Drug: Ibuprofen-LDH |
| Part C Ibuprofen LDH Excipient Combo 3 | Experimental | Not described Receives: Drug: Ibuprofen-LDH |
| Part B Ibuprofen LDH Excipient Combo 5 | Experimental | Not described Receives: Drug: Ibuprofen-LDH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Measured: 12 hours
AUC(0-inf)
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2016 (estimated)
- Study startDec 2016
- Primary completion28 Apr 2017
- Study completion3 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford Pharmascience Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Annelize Koch, Principal investigator, Simbec Orion Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02974361
- Sponsor's protocol ID
- OAT-01
- Status last verified
- May 2017
- First submitted
- 21 Nov 2016
- Last updated
- 3 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-dose, Randomised, Crossover Study to Evaluate Changes in the Pharmacokinetics of Ibuprofen From Ibuprofen-LDH Dosed With and Without Release Modifying Excipients in Normal, Healthy, Adult Subjects
- ClinicalTrials.gov ID
- NCT02974361
- Acronym / sponsor ID
- OAT-01
- Conditions
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Oxford Pharmascience LtdIndustry (pharma, biotech, devices)
- Study start
- Dec 2016
- Primary completion
- 28 Apr 2017 (actual)
- Study completion
- 3 May 2017 (actual)
- First posted
- 28 Nov 2016 (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 study is to help development of a new version of Ibuprofen, called Ibuprofen-LDH. Ibuprofen-LDH will be used as a treatment for muscular pains, headache, fever etc. This new version of ibuprofen is expected to produce fewer stomach/intestine related side effects when compared to many existing marketed formulations of Ibuprofen.
This study is split into 3 parts. Part A is a 7 way crossover, Part B is a maximum of a 6 way crossover and Part C is a maximum of a 4 way crossover. The size of Parts B \& Part C and allocated interventions will be confirmed after review of data from Parts A and/or B respectively.
A total of 30 subjects will take part in the study; 10 per study part.
The key objective is to assess the pharmacokinetics properties of Ibuprofen-LDH, with and without a selection of different excipients. The pharmacokinetic properties will include how quickly the drug is absorbed into the bloodstream and also the maximum concentration of drug that reaches the bloodstream.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 17
| Arm | Type | Receives |
|---|---|---|
| Part A Ibuprofen control | Active comparator | Drug: Ibuprofen |
| Part A Ibuprofen-LDH | Experimental | Drug: Ibuprofen-LDH |
| Part A Ibuprofen-LDH Excipient Combo 1 | Experimental | Drug: Ibuprofen-LDH |
| Part A Ibuprofen-LDH Excipient Combo 2 | Experimental | Drug: Ibuprofen-LDH |
| Part A Ibuprofen-LDH Excipient Combo 3 | Experimental | Drug: Ibuprofen-LDH |
| Part A Ibuprofen-LDH Excipient Combo 4 | Experimental | Drug: Ibuprofen-LDH |
| Part A Ibuprofen Lysine | Active comparator | Drug: Ibuprofen Lysine |
| Part B Ibuprofen | Active comparator | Drug: Ibuprofen |
| Part B Ibuprofen LDH Excipient Combo 1 | Experimental | Drug: Ibuprofen-LDH |
| Part B Ibuprofen LDH Excipient Combo 2 | Experimental | Drug: Ibuprofen-LDH |
| Part B Ibuprofen LDH Excipient Combo 3 | Experimental | Drug: Ibuprofen-LDH |
| Part B Ibuprofen LDH Excipient Combo 4 | Experimental | Drug: Ibuprofen-LDH |
| Part C Ibuprofen | Active comparator | Drug: Ibuprofen |
| Part C Ibuprofen LDH Excipient Combo 1 | Experimental | Drug: Ibuprofen-LDH |
| Part C Ibuprofen LDH Excipient Combo 2 | Experimental | Drug: Ibuprofen-LDH |
| Part C Ibuprofen LDH Excipient Combo 3 | Experimental | Drug: Ibuprofen-LDH |
| Part B Ibuprofen LDH Excipient Combo 5 | Experimental | Drug: Ibuprofen-LDH |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male or female subjects
- BMI 18 - 30 kg/m2
- Willing and able to provide written informed consent
Key exclusion criteria (3 listed)
- Evidence or history of significant renal, hepatic, gastrointestinal, central nervous system, respiratory, cardiovascular, autoimmune or metabolic dysfunction
- Recent or concurrent use of prescription or non-prescription medications, other than contraceptives
- Allergy or sensitivity to NSAIDs
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 |
|---|---|---|
| Ibuprofen | Drug | Part A Ibuprofen control, Part B Ibuprofen, Part C Ibuprofen |
| Ibuprofen Lysine | Drug | Part A Ibuprofen Lysine |
| Ibuprofen-LDH | Drug | Part A Ibuprofen-LDH, Part A Ibuprofen-LDH Excipient Combo 1, Part A Ibuprofen-LDH Excipient Combo 2, Part A Ibuprofen-LDH Excipient Combo 3, Part A Ibuprofen-LDH Excipient Combo 4, Part B Ibuprofen LDH Excipient Combo 1, Part B Ibuprofen LDH Excipient Combo 2, Part B Ibuprofen LDH Excipient Combo 3, Part B Ibuprofen LDH Excipient Combo 4, Part B Ibuprofen LDH Excipient Combo 5, Part C Ibuprofen LDH Excipient Combo 1, Part C Ibuprofen LDH Excipient Combo 2, Part C Ibuprofen LDH Excipient Combo 3 |
Primary outcome
Cmax
Time frame: 12 hours
AUC(0-inf)
Time frame: 12 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 3 May 2017.
Related trials for Pharmacokinetics
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingPhase 2
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
Carcinoma, Neuroendocrine, Tumor, Neuroendocrine
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
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.
Annelize Koch principal investigator
Simbec Orion 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 Ibuprofen, Ibuprofen Lysine and Ibuprofen-LDH in people with Pharmacokinetics, run by Oxford Pharmascience 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 3 inclusion and 3 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 3 May 2017. 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?
Cmax (time frame: 12 hours). 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?
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 3 May 2017.