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- Sperimentazione clinica NCT00622115
Etude (Study) Phase I Enox - UnFractionated Heparin (UFH)
14 marzo 2011 aggiornato da: Sanofi
A Phase I, Pharmacokinetic and Tolerability Study of Intravenous Unfractionated Heparin After Subcutaneous Enoxaparin 1mg/kg Bid Repeated Administration in Healthy Subjects
Primary objective:
- to characterize the pharmacokinetic and the pharmacodynamic profile after intravenous bolus injection of unfractionated heparin (UFH) after repeated sc 100 IU anti-Xa/kg (corresponding to 1 mg/kg) twice a day during 2.5 days (every 12±2hrs) administrations of enoxaparin in Caucasian healthy subjects.
Secondary objective(s):
- to compare the pharmacokinetic and the pharmacodynamic profile between 3 different timing of administration of the UFH
- to assess the tolerability of the different anticoagulation protocols
Panoramica dello studio
Tipo di studio
Interventistico
Iscrizione (Effettivo)
72
Fase
- Fase 1
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Paris, Francia
- Sanofi-Aventis Administrative Office
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 40 anni a 60 anni (Adulto)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Caucasian
- Male and female subjects, between 40 and 60 years of age
- Body weight between 50 kg and 90 kg if male and between 40 and 80 kg if female with Body Mass Index (BMI) between 18 and 29 kg/m2
Health Status:
- Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination)
- Subject with hypertension, hypo- or hyperthyroidism or dyslipidemia will be included if their concomitant pathology is well-controlled by treatment for at least one year
Normal vital signs after 10 minutes resting in supine position:
- 95 mmHg < systolic blood pressure (SBP) < 140 mmHg;
- 45 mmHg < diastolic blood pressure (DBP) < 90 mmHg;
- 40 bpm < heart rate < 100 bpm.
- Normal 12-lead electrocardiogram (ECG); 120 ms < PR < 220 ms, QRS < 120 ms, QTc ≤ 430 ms for male, 450 ms for female or not considered as clinically significant by the investigator
- Laboratory parameters within the normal range unless the Investigator considers an abnormality to be clinically irrelevant for healthy subjects; hepatic enzymes (aspartate amino-transferase or AST, alanine amino-transferase or ALT) should be strictly below the upper laboratory norm.
- Platelets ≥ 150 000 / mm3
- Mean corpuscular volume (MCV) and gamma glutamyl-transferase (GGT) should be strictly in the normal range of the laboratory
- Activated partial thromboplastin time (aPTT) ratio should be comprised between 0.95 and 1.15
- Estimated Creatinine clearance by Cockroft formula should be higher than 50 mL/min
- Non smoker or smoking the equivalent or less than 5 cigarettes a day and able not to smoke during the study hospitalization
- Normal gynecological examination no longer than 12 months before inclusion.
- For female with childbearing potential using an effective contraception method (e.g. intra-uterine device, hormonal contraception, diaphragm and condom) except if postmenopausal for more than 12 months or sterilized for more than three months
- Subject with coagulation test and blood count (including platelets) within the physiological ranges)
Regulations:
- Having given written informed consent prior to any procedure related to the study
- Covered by Health Insurance System and/or in compliance with the recommendations of National Law in force relating to biomedical research
- Not under any administrative or legal supervision
Exclusion Criteria:
Medical history and clinical status:
- Contra-indication to anticoagulant therapy
- Subject with known increased bleeding time, hemophilia, thrombocytopenia, and/or history of any vascular purpura
- Subject with detectable antibody against heparin in the blood
- Any history or presence of clinically relevant cardiovascular, gynecologic (for women), pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic, ocular or infectious disease that is capable of altering the absorption, metabolism, or elimination of drugs, or of constituting a risk factor when taking the study medication; any acute infectious disease or signs of acute illness; except subject with hypertension, hypo- or hyperthyroidism or dyslipidemia if well-controlled by treatment for at least one year.
- Subject with diabetes or other cardiovascular or metabolic disease
- Subject with INR > 1.5
- Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month)
- Blood donation or blood loss within one month before administration
- Symptomatic hypotension whatever the decrease in blood pressure or asymptomatic postural hypotension defined by a decrease in SBP equal to or greater than 20 mmHg within three minutes when changing from the supine to the standing position
- Presence or history of drug allergy, or allergic disease diagnosed and treated by a physician
- History or presence of drug or alcohol abuse (alcohol consumption > 40 grams/day)
- Smoking more than 5 cigarettes or equivalent/day, or unable to stop smoking during the study
- Excessive consumption of beverages with xanthine bases (> 4 cups or glasses/day)
- Pregnancy (defined as positive beta-HCG plasma test that can not be explicated by menopauses), breast-feeding for female, any history or presence of clinically relevant gynecologic disease
Interfering substance:
- Any medication (including St John's Wort) within 14 days before administration, or within 5 times the elimination half-life of that drug, except for hormonal contraception or replacement therapy, and allowed therapy for stable pathology
- Anti-inflammatory treatments and anti-aggregant treatments are strictly forbidden during the whole study period
General conditions:
- Subject who, in the judgment of the Investigator, is likely to be non-compliant during the study, or unable to cooperate because of a language problem or poor mental development
- Subject in exclusion period of a previous study according to applicable regulations
- Subject who cannot be contacted in case of emergency
- Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff thereof, directly involved in the conduct of the protocol or any other protocol of the Investigating Center
- Subject is an employee of the Investigating Center
Biological status:
- Positive reaction to any of the following tests: HBs antigen, anti-HCV antibodies, anti-HIV1 antibodies, anti-HIV2 antibodies, anti-LMWH antibodies
- Positive results on urine drug screen (amphetamines/metamphetamines, barbiturates, benzodiazepines, cannabinoids)
- Positive alcohol breath or plasma test
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: A
70 U/kg of UnFractionated Heparin (UFH) administered intravenously at 4 hours following the last injection of enoxaparin
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Sperimentale: B
70 U/kg of UnFractionated Heparin (UFH) administered intravenously at 6 hours following the last injection of enoxaparin
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Sperimentale: C
70 U/kg of UnFractionated Heparin (UFH) administered intravenously at 10 hours following the last injection of enoxaparin
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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Concentration-time profiles of anti-Xa and anti-IIa levels
Lasso di tempo: At baseline (Day 2) after the morning enoxaparin injection and at day 3 from pre-dose of enoxaparin and lasting until 14 hours after the enoxaparin injection.
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At baseline (Day 2) after the morning enoxaparin injection and at day 3 from pre-dose of enoxaparin and lasting until 14 hours after the enoxaparin injection.
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
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Effect-time profiles of ACT, TGTppp and TGTprp
Lasso di tempo: At baseline (Day 2) after the morning enoxaparin sc injection and at day 3 from pre-dose of enoxaparin and lasting until 14 hours after the enoxaparin injection.
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At baseline (Day 2) after the morning enoxaparin sc injection and at day 3 from pre-dose of enoxaparin and lasting until 14 hours after the enoxaparin injection.
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PFA100 levels measured
Lasso di tempo: At pre-dose, 4h and 14h post dose of enoxaparin
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At pre-dose, 4h and 14h post dose of enoxaparin
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Documentation of adverse event, physical examination, clinical laboratory safety, vital signs and ECG recording at prespecified time-points.
Lasso di tempo: during the entire study
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during the entire study
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: Kazuki Otani, Sanofi
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 luglio 2007
Completamento primario (Effettivo)
1 novembre 2007
Completamento dello studio (Effettivo)
1 novembre 2007
Date di iscrizione allo studio
Primo inviato
13 febbraio 2008
Primo inviato che soddisfa i criteri di controllo qualità
21 febbraio 2008
Primo Inserito (Stima)
22 febbraio 2008
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
15 marzo 2011
Ultimo aggiornamento inviato che soddisfa i criteri QC
14 marzo 2011
Ultimo verificato
1 marzo 2011
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- ENOXA_C_02537
- 2007-000884-99
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .