NCT00413088CompletedPhase 1
Clinical Trial to Assess Bemiparin Pharmacokinetics at Therapeutic (115 IU/kg) and Prophylactic Doses (3500 IU) Administered Subcutaneously in Single or Multiple Doses in Renal Insufficiency and in the Elderly
Rovi Pharmaceuticals Laboratories2 sites in 1 country60 target enrollmentStarted: March 1, 2006Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- To assess the pharmacokinetics of bemiparin administered subcutaneously once daily for 4 days at prophylactic doses (3500 IU) and at a single therapeutic dose (115 IU/kg), in renal insufficiency and in the elderly.
Study Overview
Brief Summary
Open pharmacokinetic study with 5 parallel groups and two treatment phases (bemiparin 3,500 IU multiple dose and bemiparin 115 IU/kg single dose). The bemiparin pharmacokinetic profile will be assessed by measuring its effects on the coagulation cascade. Plasma anti-Xa activity (measured using chromogenic amidolytic assay) in IU per milliliter will be the primary endpoint to assess the pharmacokinetic profile of bemiparin.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Non-elderly healthy volunteers (Group I):
- •Male or female subjects aged between 18 and 65 years
- •body weight, clinical history, physical examination, vital signs (systolic and diastolic blood pressure, heart beat rate and body temperature), ECG and laboratory tests (hemogram and biochemistry) within normal range
- •without evidence of significant organic or psychiatric illness
- •who have accepted to participate in the study and have signed the written informed consent.
- •Patients with renal insufficiency (Groups II, III and IV):
- •Male or female subjects aged between 18 and 65 years, who will be assigned to one of the following groups according to renal function:
- •Group II: mild renal insufficiency (creatinine clearance > 50 to 80 ml/min);
- •Group III: Moderate renal insufficiency (creatinine clearance: 30 to 50 ml/min);
- •Group IV: Severe renal insufficiency (creatinine clearance < 30 ml/min). The degree of renal insufficiency will be calculated on the basis of determination of creatinine clearance measuring total urinary output over a 24-h period and serum creatinine levels. Urine samples will be collected no more than 2 weeks before the first experimental period.
- •Patients with renal insufficiency must have a stable renal function during the 3 months before their inclusion in the study.
- •They must have a body weight between 45 and 110 Kg.
- •They have to accept to participate in the study and have signed the written informed consent.
- •Elderly healthy volunteers (Group V):
- •Male or female subjects aged > 65 years old who fulfill with the remaining inclusion criteria specified for non-elderly healthy volunteers.
Exclusion Criteria
- •Non-elderly healthy volunteers (Group I):
- •Previous history of alcoholism or drugs consumption
- •Important consumer of exciting drinks
- •Hypersensitivity, allergy, idiosyncrasy to medicines
- •Taking another medication four weeks before the initiation of the trial including medication without prescription and medicinal plants
- •Positive serology of hepatitis B, C or HIV virus
- •History or clinic evidence of concomitant disease
- •Familiar history of coagulation's disorders
- •surgery within the previous 6 months
- •Women who are pregnant or who are not using effective contra conceptive methods
- •Ethanol, cannabis, cocaine, amphetamine, benzodiazepin or opiate in urine
- •Current platelet count < 100.000/mm3 or serum K > 5,5 mEq/L
- •Any contraindication to bemiparin administration in order to authorized summary product characteristics
- •Healthy volunteers who are not participating in another clinical trial or have not done so in the past 2 months
- •To give blood in the four weeks before beginning of the trial
- •Patients with renal insufficiency or elderly healthy volunteers (Groups II, III, IV, V):
- •Previous history of alcoholism or drugs consumption
- •Important consumer of exciting drinks
- •Hypersensitivity, allergy, idiosyncrasy to medicines
- •Treatment with enzymatic inhibitors or inductors medicines
- •Administration with ASA of dosis > 125 mg/day and/or NDAIs with half-life > 20 hours or with high antiagregant effect during the previous ten days to the inclusion
- •Chronic hepatopatology
- •bilirubin levels > 1,5 mg/dl and/or increment of AST/ALT levels twice higher than maximum limit of normality
- •prothrombin time 20% higher than maximun limit of normality and haemoglobine < 8gr/dl or albumim levels <3gr/dl
- •Previous history of acute infarction of myocardium, cardiac ischemic or arrhythmia
- •Acute illness in the previous week to the participation
- •Familiar history of coagulation's disorders
- •surgery within the previous 6 months
- •Women who are pregnant or who are not using effective contra conceptive methods
- •Ethanol, cannabis, cocaine, amphetamine, benzodiazepin or opiate in urine
- •Current platelet count < 75.000/mm3 or serum K > 6 mEq/L
- •Any contraindication to bemiparin administration in order to authorized summary product characteristics
- •Healthy volunteers who are not participating in another clinical trial or have not done so in the past 2 months
- •To give blood in the four weeks before beginning of the trial
- •Subjects in haemodialysis or peritoneal dialysis
Outcomes
Primary Outcomes
To assess the pharmacokinetics of bemiparin administered subcutaneously once daily for 4 days at prophylactic doses (3500 IU) and at a single therapeutic dose (115 IU/kg), in renal insufficiency and in the elderly.
Secondary Outcomes
- To assess the safety and tolerability of bemiparin in all volunteers and patients.
Investigators
Study Sites (2)
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