Renal HemodynamicsPhase 1NCT00909519
Effect of Repeated Dosing of Naproxcinod on Renal Hemodynamic and on Sodium Balance in Healthy Volunteers Before and After a Single Dose of Furosemide
A Phase 1 study testing naproxcinod, Naproxen and furosemide in people with Renal Hemodynamics, run by NicOx.
Trial summary
This phase 1 study is an 8-day treatment period, randomized, controlled, double-blind, 3 parallel-groups, monocentric study. The primary objective is to evaluate the effect of naproxcinod on the renal function when co-administered with furosemide in comparison to naproxen and placebo. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Renal Hemodynamics
- What is being tested?
- naproxcinod, Naproxen and furosemide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Apr 2009
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, non smoker male subjects aged 18 and 35 years (inclusive), at the Screening visit.
- Body Mass Index (BMI) strictly between 18 and 30 kg/m² (inclusive) with body weight≥ 50 kg at the Screening visit.
- Normal physical examination at the Screening visit.
- Normal ECG (12-lead) at the Screening visit, as judged by the Investigator.
- At Screening and run-in period visits , Systolic Blood Pressure (SBP) between 100 and 139 mmHg (inclusive) and Diastolic Blood Pressure (DBP) between 50 and 89 mmHg (inclusive).
- At Screening and run-in period visits, HR between 45 and 90 bpm (inclusive).
- Subjects must be able to understand the written information sheet and informed consent and comply with all study requirements.
- Subjects must provide a written, dated and signed informed consent prior to any study procedure.
Who cannot join
- A history of hypersensitivity reactions (such as asthma, rhinitis, or urticaria) to aspirin, naproxen or any other NSAIDs; or hypersensitivity or contraindications to organic nitrate drugs or hypersensitivity to furosemide or to sinistrine or PAH.
- Family history of hypertension which may disqualify the subject, as judged by the investigator..
- History of any clinically relevant gastrointestinal (such as gastritis or gastric ulcer), respiratory, psychiatric, neurologic, kidney, liver, cardiac disease, bleeding disorder, other disease/condition or abnormal physical finding which may interfere with the study objectives. The investigator may disqualify any subject for a sound medical or psychiatric reason.
- History or presence of ASAT >40UI/L, ALAT >40UI/L, serum bilirubin 3 times above the Upper Limit of Normal range at the Screening visit.
- Creatinine clearance inferior/equal to 80 ml/min as calculated with the Cockcroft-Gault formula (Appendix 5 of the protocol) at the Screening visit.
- Plasmatic potassium <3.5 mmole/L at the Screening visit.
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- Seropositivity for HBs, HBc, HIV 1 or HIV 2 at the Screening visit.
- Donations of blood, plasma or platelets within 3 months prior to the Screening visit or donation planned during the 3 months following Day 8.
- Any clinically significant abnormal laboratory values at the Screening visit.
- At the Screening visit, after 1 minute in a standing position, a drop of more than 20 mmHg in SBP or 10 mmHg in DBP or a clinical manifestation of postural hypotension.
- Chronic use of any drugs (prescription or OTC) within 4 weeks prior to Visit 2 (single use of medication such as paracetamol for headache will be tolerated at the lowest possible dose).
- Intake of any Nitric Oxide Synthase Inhibitor within 1 month before Screening visit.
- History of drug addiction or alcohol abuse as defined by DSM IVR, diagnostic criteria for drug and alcohol abuse or drug addiction.
- Positive drug screening (opiates, cannabinoids, cocaine, benzodiazepines, amphetamines, barbiturates) at the Screening visit.
- Current participation or participation within 60 days prior to the Screening visit, in another investigational study, including the present study or any previous enrolment in a naproxcinod study.
- In custody due to an administrative or a legal decision, or under tutelage, or being admitted to a sanitary or social institution.
- Any direct or indirect involvement with the study conduct or staff at site or any family link with study site staff.
About this study
Official title: A Phase 1, Single-Center, Randomized, Parallel-group, Placebo- and Naproxen- Controlled, Double-blind Study to Evaluate the Effect of Naproxcinod 750 mg Bid Administered for 8 Days on the Renal Hemodynamics, Natriuretic and Renin Responses to a Single Bolus IV Dose of Furosemide 40 mg in Male Healthy Normotensive Volunteers
This phase 1 study is an 8-day treatment period, randomized, controlled, double-blind, 3 parallel-groups, monocentric study. The primary objective is to evaluate the effect of naproxcinod on the renal function when co-administered with furosemide in comparison to naproxen and placebo.
- Conditions
- Renal Hemodynamics
- Being tested
- naproxcinod, Naproxen, placebo, furosemide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
naproxcinodDrug
naproxcinod 750 mg bid
NaproxenDrug
Naproxen 500 mg bid
placeboDrug
placebo
furosemideDrug
furosemide
| Study group | Role | What they receive |
|---|---|---|
| naproxen | Active comparator | Not described Receives: Drug: Naproxen |
| naproxcinod | Experimental | Not described Receives: Drug: naproxcinod; Drug: furosemide |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of naproxcinod on the renal function when co-administered with furosemide in comparison to naproxen and placebo
Measured: Day 8, between H3 and H9
Secondary outcomes (2)
to assess the effect of naproxcinod on blood pressure (BP) in comparison with naproxen and placebo over 1 week and when co-administered with furosemide + to assess the general safety and tolerability
Measured: for over 1 week
To evaluate the effect of naproxcinod when administered alone on renal function, after a week of administration, in comparison with naproxen and placebo.
Measured: Day 8 at H4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2009 (estimated)
- Study startJan 2009
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal HemodynamicsStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- NicOx
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00909519
- Sponsor's protocol ID
- HCT3012-X-113
- Status last verified
- Jun 2011
- First submitted
- 27 May 2009
- Last updated
- 17 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Center, Randomized, Parallel-group, Placebo- and Naproxen- Controlled, Double-blind Study to Evaluate the Effect of Naproxcinod 750 mg Bid Administered for 8 Days on the Renal Hemodynamics, Natriuretic and Renin Responses to a Single Bolus IV Dose of Furosemide 40 mg in Male Healthy Normotensive Volunteers
- ClinicalTrials.gov ID
- NCT00909519
- Acronym / sponsor ID
- HCT3012-X-113
- Conditions
- Renal Hemodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- NicOxIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 28 May 2009 (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 phase 1 study is an 8-day treatment period, randomized, controlled, double-blind, 3 parallel-groups, monocentric study. The primary objective is to evaluate the effect of naproxcinod on the renal function when co-administered with furosemide in comparison to naproxen and placebo.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| naproxen | Active comparator | Drug: Naproxen |
| naproxcinod | Experimental | Drug: naproxcinod, Drug: furosemide |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy, non smoker male subjects aged 18 and 35 years (inclusive), at the Screening visit.
- Body Mass Index (BMI) strictly between 18 and 30 kg/m² (inclusive) with body weight≥ 50 kg at the Screening visit.
- Normal physical examination at the Screening visit.
- Normal ECG (12-lead) at the Screening visit, as judged by the Investigator.
- At Screening and run-in period visits , Systolic Blood Pressure (SBP) between 100 and 139 mmHg (inclusive) and Diastolic Blood Pressure (DBP) between 50 and 89 mmHg (inclusive).
Key exclusion criteria (17 listed)
- A history of hypersensitivity reactions (such as asthma, rhinitis, or urticaria) to aspirin, naproxen or any other NSAIDs; or hypersensitivity or contraindications to organic nitrate drugs or hypersensitivity to furosemide or to sinistrine or PAH.
- Family history of hypertension which may disqualify the subject, as judged by the investigator..
- History of any clinically relevant gastrointestinal (such as gastritis or gastric ulcer), respiratory, psychiatric, neurologic, kidney, liver, cardiac disease, bleeding disorder, other disease/condition or abnormal physical finding which may interfere with the study objectives. The investigator may disqualify any subject for a sound medical or psychiatric reason.
- History or presence of ASAT >40UI/L, ALAT >40UI/L, serum bilirubin 3 times above the Upper Limit of Normal range at the Screening visit.
- Creatinine clearance inferior/equal to 80 ml/min as calculated with the Cockcroft-Gault formula (Appendix 5 of the protocol) at the Screening visit.
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 |
|---|---|---|
| naproxcinodnaproxcinod 750 mg bid | Drug | naproxcinod |
| NaproxenNaproxen 500 mg bid | Drug | naproxen |
| placeboplacebo | Drug | placebo |
| furosemidefurosemide | Drug | naproxcinod |
Primary outcome
To evaluate the effect of naproxcinod on the renal function when co-administered with furosemide in comparison to naproxen and placebo
Time frame: Day 8, between H3 and H9
2 secondary outcomes
to assess the effect of naproxcinod on blood pressure (BP) in comparison with naproxen and placebo over 1 week and when co-administered with furosemide + to assess the general safety and tolerability
Time frame: for over 1 week
To evaluate the effect of naproxcinod when administered alone on renal function, after a week of administration, in comparison with naproxen and placebo.
Time frame: Day 8 at H4
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 17 Jun 2011.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing naproxcinod, Naproxen and furosemide in people with Renal Hemodynamics, run by NicOx.
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 8 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 17 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
To evaluate the effect of naproxcinod on the renal function when co-administered with furosemide in comparison to naproxen and placebo (time frame: Day 8, between H3 and H9). 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 17 Jun 2011.