Pharmacokinetics of Certoparin in Subjects With Renal Insufficiency and Healthy Subjects

Study Overview
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Brief Summary
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This study will assess the pharmacokinetics in subjects with severe renal insufficiency and healthy subjects.

Official Title
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An Open-label, Single Center, Parallel-group Study to Compare the Single- and Repeated-dose Pharmacokinetics of Stepwise Increasing Doses of Subcutaneous Certoparin (3000 IU o.d., 3000 IU b.i.d., 8000 IU o.d., and 8000 IU b.i.d.) in Subjects With Severe Renal Insufficiency and Healthy Subjects

Conditions
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Renal Insufficiency

Intervention / Treatment
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* Drug: Certoparin 3,000 IU Once Daily
* Drug: Certoparin 3,000 IU Twice a Day
* Drug: Certoparin 8,000 IU Once Daily
* Drug: Certoparin 8,000 IU Twice a Day


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Healthy subjects OR Subjects with severe renal insufficiency Exclusion criteria: Hypersensitivity to study medication Genetic abnormality or disease of clotting system Prior major surgery or bleeding Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Certoparin control<br>Participants receive Certoparin 3,000 IU during period 1. Participants will receive 8,000 IU during period 2, if qualified as per medical criteria. | Drug: Certoparin 3,000 IU Once Daily<br>* Certoparin 3,000 IU subcutaneous injection once daily<br>* Other names: Mono-Embolex;Drug: Certoparin 8,000 IU Twice a Day<br>* Certoparin 8,000 IU subcutaneous injection twice a day<br>* Other names: Mono-Embolex;|
| Experimental: Certoparin Renal<br>Participants receive dose escalation upon medical criteria qualification at each period: Certoparin 3,000 IU once a day during period 1. Certoparin 3,000 IU twice a day during period 2. Certoparin 8,000 IU once a day during period 3. Certoparin 8,000 IU in the morning and 3,000 IU in the evening during period 4 OR Certoparin 8,000 IU twice a day during period 4. | Drug: Certoparin 3,000 IU Once Daily<br>* Certoparin 3,000 IU subcutaneous injection once daily<br>* Other names: Mono-Embolex;Drug: Certoparin 3,000 IU Twice a Day<br>* Certoparin 3,000 IU subcutaneous injection twice a day<br>* Other names: Mono-Embolex;Drug: Certoparin 8,000 IU Once Daily<br>* Certoparin 8,000 IU subcutaneous injection once daily<br>* Other names: Mono-Embolex;Drug: Certoparin 8,000 IU Twice a Day<br>* Certoparin 8,000 IU subcutaneous injection twice a day<br>* Other names: Mono-Embolex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma aXa-Profile: C0 | Estimate of the effects of renal insufficiency on the systemic exposure to aXa for once daily (τ = 24 h) repeated doses of 3,000 IU aXa as characterized by pre-dose trough (C0,ss) aXa comparing REN-patients with matched CON-subjects studied in parallel. | 5 days | 
| Dose regimen, systemic total exposure to aXa (AUC0-τ,ss) | Dosage regimen (3,000 o.d., 3,000 b.i.d., 8,000 o.d., 8,000 IU aXa in the morning plus 3,000 IU aXa in the evening, or 8,000 b.i.d. IU aXa) that yields a systemic total exposure to aXa (AUC0-τ,ss) in REN-patients similar to that achieved with 8,000 b.i.d. IU aXa in CON-subjects. | 5 days | 
| Plasma aXa-Profile: Cmax | Estimate of the effects of renal insufficiency on the systemic exposure to aXa for once daily (τ = 24 h) repeated doses of 3,000 IU aXa as characterized by maximum (Cmax,ss), aXa comparing REN-patients with matched CON-subjects studied in parallel. | 5 days | 
| Plasma aXa-Profile: AUC | Estimate of the effects of renal insufficiency on the systemic exposure to aXa for once daily (τ = 24 h) repeated doses of 3,000 IU aXa as characterized by total (AUC0-τ,ss) aXa comparing REN-patients with matched CON-subjects studied in parallel. | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Severe renal insufficiency certoparin, Severe renal insufficiency