Healthy VolunteersPhase 1/2NCT00966641
Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adults
A Phase 1/2 study testing Naproxen and PL 3100 in people with Healthy Volunteers, run by PLx Pharma at 1 site in United States.
Trial summary
The purpose of this study is to determine the single-dose pharmacokinetics of the investigational drug PL 3100 following oral administration to healthy volunteers and to compare the pharmacokinetic profiles of PL 3100 and naproxen at a prescription dose. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Naproxen and PL 3100
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Oct 2009
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-75 years, inclusive.
- Subject has a Body Mass Index (BMI) between 20 and 32, inclusive.
- Normal physical examination as determined by the Investigator.
- Normal clinical laboratory test results or clinically insignificant results as determined by the Investigator during the screening visit.
- If female and of child-bearing potential, the subject must have a negative pregnancy test and is not nursing.
- If female and of child-bearing potential, the subject must agree to use adequate birth control for the duration of the study.
Who cannot join
- Subject has a history of chronic alcohol consumption or abuse of narcotics or alcohol.
- Subject has had an acute illness within 5 days of study medication administration.
- Subject is currently participating, or has participated within 30 days prior to study entry, in an investigational drug study.
- Subject has hypersensitivity or contraindications to naproxen, ibuprofen, or other NSAID.
Trial locations and contacts
1 site in 1 country.
United States1 site
Houston Institute for Clinical Research
Houston, Texas, 77074
About this study
Official title: "A Single-Dose Crossover Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adult Volunteers in the Fasted State"
The purpose of this study is to determine the single-dose pharmacokinetics of the investigational drug PL 3100 following oral administration to healthy volunteers and to compare the pharmacokinetic profiles of PL 3100 and naproxen at a prescription dose.
- Conditions
- Healthy Volunteers
- Being tested
- Naproxen, PL 3100
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaproxenDrug
Single orally administered dose of 500 mg naproxen
PL 3100Drug
Also called Naproxen-PC
Single orally administered dose of PL 3100 (500 mg naproxen)
| Study group | Role | What they receive |
|---|---|---|
| PL 3100 | Experimental | Active experimental drug Receives: Drug: PL 3100 |
| Naproxen | Active comparator | Active comparator Receives: Drug: Naproxen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve of Plasma Naproxen From 0 to t
Blood samples for evaluation of PK variables were collected over a 48-hour period after drug administration.
Measured: 30 minutes prior to administration; 30, 60, and 90 minutes post drug administration; and 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, and 48 hours post drug administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- PLx Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Upendra K. Marathi, PhD, Principal investigator, PLx Pharma Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00966641
- Sponsor's protocol ID
- PL-NAP-001
- Other IDs
- NIH Grant 1R44AR056529-01
- Status last verified
- Aug 2015
- First submitted
- 25 Aug 2009
- Last updated
- 7 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "A Single-Dose Crossover Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adult Volunteers in the Fasted State"
- ClinicalTrials.gov ID
- NCT00966641
- Acronym / sponsor ID
- PL-NAP-001
- Conditions
- Healthy Volunteers
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- PLx PharmaIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Aug 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 27 Aug 2009 (estimated)
- Results
- Posted 7 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the single-dose pharmacokinetics of the investigational drug PL 3100 following oral administration to healthy volunteers and to compare the pharmacokinetic profiles of PL 3100 and naproxen at a prescription dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PL 3100 | Experimental | Drug: PL 3100Active experimental drug |
| Naproxen | Active comparator | Drug: NaproxenActive comparator |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-75 years, inclusive.
- Subject has a Body Mass Index (BMI) between 20 and 32, inclusive.
- Normal physical examination as determined by the Investigator.
- Normal clinical laboratory test results or clinically insignificant results as determined by the Investigator during the screening visit.
- If female and of child-bearing potential, the subject must have a negative pregnancy test and is not nursing.
Key exclusion criteria (4 listed)
- Subject has a history of chronic alcohol consumption or abuse of narcotics or alcohol.
- Subject has had an acute illness within 5 days of study medication administration.
- Subject is currently participating, or has participated within 30 days prior to study entry, in an investigational drug study.
- Subject has hypersensitivity or contraindications to naproxen, ibuprofen, or other NSAID.
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 |
|---|---|---|
| NaproxenSingle orally administered dose of 500 mg naproxen | Drug | Naproxen |
| PL 3100Also: Naproxen-PCSingle orally administered dose of PL 3100 (500 mg naproxen) | Drug | PL 3100 |
Primary outcome
Area Under the Curve of Plasma Naproxen From 0 to t
Time frame: 30 minutes prior to administration; 30, 60, and 90 minutes post drug administration; and 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, and 48 hours post drug administration.
Blood samples for evaluation of PK variables were collected over a 48-hour period after drug administration.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Upendra K. Marathi, PhD principal investigator
PLx Pharma Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Naproxen and PL 3100 in people with Healthy Volunteers, run by PLx Pharma 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 6 inclusion and 4 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 7 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 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 of Plasma Naproxen From 0 to t (time frame: 30 minutes prior to administration; 30, 60, and 90 minutes post drug administration; and 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, and 48 hours post drug administration.). 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 7 Sep 2015.