Status:
COMPLETED
Pharmacokinetics Study: Determination of Naproxcinod and Its Metabolites After Oral Administration in Male
Lead Sponsor:
NicOx
Conditions:
Pharmacokinetics
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief 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 m...
Eligibility Criteria
Inclusion
- 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).
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01404598
Start Date
January 1 2010
End Date
February 1 2010
Last Update
August 11 2011
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