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PharmacokineticsPhase 1NCT01404598

Pharmacokinetics Study: Determination of Naproxcinod and Its Metabolites After Oral Administration in Male

A Phase 1 study testing naproxcinod 750 bid, naproxcinod 3000 mg od and naproxen 500 mg bid in people with Pharmacokinetics, run by NicOx.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will be performed in 2 parts conducted in parallel: Part 1 (conducted on 16 healthy subjects): Administration of naproxcinod 750 mg or naproxen 500 mg twice a day (bid) during 7 days The main aim of this study part will be to assess the pharmacokinetic profile (i.e. Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Pharmacokinetics
What is being tested?
naproxcinod 750 bid, naproxcinod 3000 mg od and naproxen 500 mg bid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
No sites listed yet
Study dates
Jan 2010to Feb 2010
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 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy, non smoker male subjects aged 18 to 45 years (inclusive).
  • Body Mass Index (BMI) between 18 and 30 kg/m² (inclusive) with body weight (BW) ≥ 50 kg.
  • Normal physical examination (non clinically significant abnormalities), as judged by the investigator.
  • Normal electrocardiogram (ECG) (12-lead), (non clinically significant abnormalities), as judged by the Investigator.
  • Supine Systolic Blood Pressure (SBP) between 100 and 139 mmHg (inclusive) and Diastolic Blood Pressure (DBP) between 50 and 89 mmHg (inclusive) (mean of 3 measurements).
  • Supine Heart Rate (HR) between 45 and 90 bpm (inclusive).
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  • Oral body temperature (BT) between 36 and 37.5°C (inclusive).
  • Subject must be able to understand the written information sheet and informed consent and comply with all study requirements.
  • Subject must provide a written, dated and signed informed consent prior to any study procedure.

Who cannot join

  • History of hypersensitivity reactions (such as asthma, rhinitis, or urticaria) to aspirin, naproxen or any other non steroidal anti-inflammatory drugs (NSAIDs); or hypersensitivity or contraindications to organic nitrate drugs; or to L-proline.
  • 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, as judged by the Investigator.
  • After 1 minute in a standing position, a drop of more than 20 mmHg in SBP or 10 mmHg in DBP compared to supine position (mean of 3 measurements) and a clinical manifestation of postural hypotension.
  • Any clinically significant abnormal laboratory values, including creatinine clearance ≤ 80 mL/min as calculated with the Cockcroft-Gault formula.
  • Seropositivity for HBs Ag, HCV Ab, HIV 1 or HIV 2 Ab.
  • Any history of alcohol or drug abuse, or addiction within the last 2 years prior to enrollment.
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  • Positive drug screening (opiates, cannabinoids, cocaine, methadone, amphetamines, barbiturates, ecstasy).
  • Positive alcohol or cotinine test.
  • Donation of blood, plasma or platelets within 3 months prior to the Screening visit or donation planned during the 3 months following the study.
  • Regular consumption of grapefruit juice or beverages containing xanthine bases (coffee, tea, cola: more than 5 cups or glasses a day).
  • Current smokers or smoking history < 6 months.
  • Current participation or participation within 3 months prior to the Screening visit, in another investigational drug or device study, or previous enrolment in the present study.
  • Chronic use of any drugs (prescription or over the counter [OTC]) within 4 weeks prior to enrollment (single use of medication such as paracetamol for headache is allowed, except during the week before enrollment).
  • Use of antioxidant vitamin supplements within 1 week prior to enrollment.
  • Use of mouthwash or toothpaste containing chlorhexidine within 1 week prior to randomization (applicable only for study Part 1).
  • 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 Study to Assess the Pharmacokinetics of Nitrates and Gamma-Hydroxybutyric Acid (GHB) After Oral Administration of Therapeutic and Supratherapeutic Doses of Naproxcinod in Healthy Male Subjects

This study will be performed in 2 parts conducted in parallel:

Part 1 (conducted on 16 healthy subjects): Administration of naproxcinod 750 mg or naproxen 500 mg twice a day (bid) during 7 days The main aim of this study part will be to assess the pharmacokinetic profile (i.e. the absorption, the distribution, the metabolism and the elimination of the drug after its administration) of nitrates (metabolite of naproxcinod) present in plasma, saliva and urine after oral administration of naproxcinod 750 mg bid for 7 days or naproxen 500 mg bid for 7 days as a reference.

Part 2 (conducted on 8 healthy subjects): Administration of a single dose of naproxcinod 3000 mg. The main aim of this study part will be to assess the pharmacokinetic profile (i.e. the absorption, the distribution, the metabolism and the elimination of the drug after its administration) of Gamma-Hydroxybutyric Acid (GHB), a compound resulting from the transformation of the naproxcinod, after oral administration of a single supratherapeutic dose of 3000 mg.

Being tested
naproxcinod 750 bid, naproxcinod 3000 mg od, naproxen 500 mg bid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • naproxcinod 750 bidDrug

    naproxcinod 750 bid

  • naproxcinod 3000 mg odDrug

    naproxcinod 3000 mg od

  • naproxen 500 mg bidDrug

    naproxen 500 mg bid

Study groups in NCT01404598
Study groupRoleWhat they receive
naproxcinod 750 mg bidExperimentalNot described
Receives: Drug: naproxcinod 750 bid
naproxcinod 3000 mg odExperimentalNot described
Receives: Drug: naproxcinod 3000 mg od
naproxen 500 mg bidActive comparatorNot described
Receives: Drug: naproxen 500 mg bid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1 : PK profile in plasma, saliva and urine : determination of nitrate levels.

    Measured: from Day 1 morning to Day 7 morning .

  2. Part 2 : PK profile in plasma : assess the Gamma-Hydroxybutyric acid (GHB) levels

    Measured: Day 1 to Day 4

Secondary outcomes (12)

  1. Part 1: PK profile in saliva : determination of nitrite levels

    Measured: from Day 1 morning to Day 7 morning .

  2. Part 2 : PK profile in plasma : determination of nitrate levels

    Measured: Day 1 to Day 4

  3. Part 1 : PK profile in plasma : determination of Gamma-Hydroxybutyric acid (GHB) levels

    Measured: from Day 1 morning to Day 7 morning

  4. Part 1 : PK profile in plasma : determination of 1,4-butanediol mononitrate (BDMN) levels

    Measured: from Day 1 morning to Day 7 morning

  5. Part 1 : PK profile in plasma : determination of naproxcinod levels

    Measured: from Day 1 morning to Day 7 morning

  6. Part 1 : PK profile in plasma : determination of naproxen levels

    Measured: from Day 1 morning to Day 7 morning

  7. Part 1 : PK profile in urine : determination of nitrosoproline levels

    Measured: from Day 1 morning to Day 7 morning

  8. Part 1 : assess the general safety and tolerability

    Measured: from Day 1 morning to Day 7 morning

  9. Part 2 : PK profile in plasma: determination of BDMN levels

    Measured: Day 1 to Day 4

  10. Part 2 : PK profile in plasma : determination of naproxcinod levels

    Measured: Day 1 to Day 4

  11. Part 2 : PK profile in plasma: determination of naproxen levels

    Measured: Day 1 to Day 4

  12. Part 2 : assess the general safety and tolerability

    Measured: Day 1 to Day 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2011 (estimated)
  2. Study startJan 2010
  3. Primary completionFeb 2010
  4. Study completionFeb 2010

Resources

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
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01404598
Sponsor's protocol ID
HCT 3012-X-114
Status last verified
Aug 2011
First submitted
16 Jun 2011
Last updated
11 Aug 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing naproxcinod 750 bid, naproxcinod 3000 mg od and naproxen 500 mg bid in people with Pharmacokinetics, 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 9 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 11 Aug 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. 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?

Part 1 : PK profile in plasma, saliva and urine : determination of nitrate levels. (time frame: from Day 1 morning to Day 7 morning .). 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?

On the ClinicalTrials.gov record for NCT01404598.

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 Aug 2011.

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