MigrainePhase 1NCT03282838
Study on the Pharmacokinetics (PK) of DFN-15 vs Comparator and Food-effect on DFN-15 PK in Healthy Adult Subjects
A Phase 1 study testing DFN-15 (fasted), DFN-15 (fed) and Comparator Celebrex® (fed) in people with Migraine, run by Dr. Reddy's Laboratories Limited at 1 site in United States.
Trial summary
An Open-Label, Three-Way Randomized, Single Dose Crossover Study Comparing Bioavailability of DFN-15 under fasting conditions versus Comparator under fed conditions and to determine food-effect of DFN-15 in Healthy Adult Subjects Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- DFN-15 (fasted), DFN-15 (fed) and Comparator Celebrex® (fed)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2017to 12 Jan 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, adult, male or female 19-55 years of age, inclusive, at screening.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee.
- Females of childbearing potential: must either be sexually inactive (abstinent) for 30 days prior to the first dose and throughout the study or be using birth control method; Female subjects of non-childbearing potential and must have undergone sterilization procedures or be postmenopausal for at least 1 year prior
- Male subject must agree to use contraception or abstain during the study until 90 days beyond the last dose of study drug.
- Understands the study procedures in the informed consent form (ICF), and willing and able to comply with the protocol.
Who cannot join
- History or presence of hypersensitivity or idiosyncratic reaction to celecoxib, sulfonamides, aspirin or other NSAIDs or related compounds
- History or presence of clinically significant medical or psychiatric condition or disease
- History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study
- liver enzyme tests greater than the upper limit of normal at screening
- Estimated creatinine clearance <90 mL/minute at screening
- History or presence of alcoholism
Show all 17Show fewer
- History or presence of bilateral pedal edema or generalized edema or fluid retention
- Female subjects who are pregnant or lactating or actively trying to conceive
- Positive urine drug or alcohol results at screening or check-in
- Positive cotinine at screening
- Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
- Seated blood pressure is less than 90/60 mmHg or greater than 140/90 mmHg at screening
- Seated heart rate is lower than 45 bpm or higher than 100 bpm at screening
- Has been on a diet incompatible with the on-study diet
- Unable to refrain from or anticipates the use of prohibited medications
- Donation of blood or significant blood loss within 56 days prior to the first dose of study drug; plasma donation within 7 days prior to the first dose of study drug
- Participation in another clinical trial within 28 days prior to the first dose of study drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-Label, Three Way, Randomized, Single Dose Crossover Study Comparing Bioavailability of DFN-15 Oral Solution Under Fasting Conditions vs Comparator Under Fed Conditions and to Determine Food Effect of DFN-15 in Healthy Adult Subjects
An Open-Label, Three-Way Randomized, Single Dose Crossover Study Comparing Bioavailability of DFN-15 under fasting conditions versus Comparator under fed conditions and to determine food-effect of DFN-15 in Healthy Adult Subjects
- Conditions
- Migraine
- Being tested
- DFN-15 (fasted), DFN-15 (fed), Comparator Celebrex® (fed)
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DFN-15 (fasted)Drug
DFN-15 administered to fasted subjects
DFN-15 (fed)Drug
DFN-15 administered to fed subjects
Comparator Celebrex® (fed)Drug
Comparator (Celebrex®) administered to fed subjects
| Study group | Role | What they receive |
|---|---|---|
| DFN-15 (fasted) | Experimental | Not described Receives: Drug: DFN-15 (fasted) |
| DFN-15 (fed) | Experimental | Not described Receives: Drug: DFN-15 (fed) |
| Comparator (fed) | Experimental | Not described Receives: Drug: Comparator Celebrex® (fed) |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFN-15 maximum plasma concentration (Cmax)
Measured: Up to 72 hours
DFN-15 area under the curve (AUC) 0-t
Measured: Up to 72 hours
DFN-15 area under the curve (AUC) 0-inf
Measured: Up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study start9 Jun 2017
- Primary completion22 Aug 2017
- Study completion12 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03282838
- Sponsor's protocol ID
- DFN-15-CD-008
- Status last verified
- Feb 2018
- First submitted
- 17 Aug 2017
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Three Way, Randomized, Single Dose Crossover Study Comparing Bioavailability of DFN-15 Oral Solution Under Fasting Conditions vs Comparator Under Fed Conditions and to Determine Food Effect of DFN-15 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT03282838
- Acronym / sponsor ID
- DFN-15-CD-008
- Conditions
- Migraine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- 9 Jun 2017 (actual)
- Primary completion
- 22 Aug 2017 (actual)
- Study completion
- 12 Jan 2018 (actual)
- First posted
- 14 Sep 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.
An Open-Label, Three-Way Randomized, Single Dose Crossover Study Comparing Bioavailability of DFN-15 under fasting conditions versus Comparator under fed conditions and to determine food-effect of DFN-15 in Healthy Adult Subjects
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DFN-15 (fasted) | Experimental | Drug: DFN-15 (fasted) |
| DFN-15 (fed) | Experimental | Drug: DFN-15 (fed) |
| Comparator (fed) | Experimental | Drug: Comparator Celebrex® (fed) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy, adult, male or female 19-55 years of age, inclusive, at screening.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee.
- Females of childbearing potential: must either be sexually inactive (abstinent) for 30 days prior to the first dose and throughout the study or be using birth control method; Female subjects of non-childbearing potential and must have undergone sterilization procedures or be postmenopausal for at least 1 year prior
- Male subject must agree to use contraception or abstain during the study until 90 days beyond the last dose of study drug.
- Understands the study procedures in the informed consent form (ICF), and willing and able to comply with the protocol.
Key exclusion criteria (17 listed)
- History or presence of hypersensitivity or idiosyncratic reaction to celecoxib, sulfonamides, aspirin or other NSAIDs or related compounds
- History or presence of clinically significant medical or psychiatric condition or disease
- History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study
- liver enzyme tests greater than the upper limit of normal at screening
- Estimated creatinine clearance <90 mL/minute at screening
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 |
|---|---|---|
| DFN-15 (fasted)DFN-15 administered to fasted subjects | Drug | DFN-15 (fasted) |
| DFN-15 (fed)DFN-15 administered to fed subjects | Drug | DFN-15 (fed) |
| Comparator Celebrex® (fed)Comparator (Celebrex®) administered to fed subjects | Drug | Comparator (fed) |
Primary outcome
DFN-15 maximum plasma concentration (Cmax)
Time frame: Up to 72 hours
DFN-15 area under the curve (AUC) 0-t
Time frame: Up to 72 hours
DFN-15 area under the curve (AUC) 0-inf
Time frame: Up to 72 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 13 Feb 2018.
- Individual participant dataSharing planned: Undecided
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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 DFN-15 (fasted), DFN-15 (fed) and Comparator Celebrex® (fed) in people with Migraine, run by Dr. Reddy's Laboratories Limited at 1 site in United States.
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 17 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 13 Feb 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 States. 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?
DFN-15 maximum plasma concentration (Cmax) (time frame: Up to 72 hours). The study lists 3 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 13 Feb 2018.