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
Overview
- Phase
- Phase 1
- Intervention
- Certoparin 3,000 IU Once Daily
- Conditions
- Renal Insufficiency
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Plasma aXa-Profile: C0
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
This study will assess the pharmacokinetics in subjects with severe renal insufficiency and healthy subjects.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Certoparin control
Participants receive Certoparin 3,000 IU during period 1. Participants will receive 8,000 IU during period 2, if qualified as per medical criteria.
Intervention: Certoparin 3,000 IU Once Daily
Certoparin control
Participants receive Certoparin 3,000 IU during period 1. Participants will receive 8,000 IU during period 2, if qualified as per medical criteria.
Intervention: Certoparin 8,000 IU Twice a Day
Certoparin Renal
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.
Intervention: Certoparin 3,000 IU Once Daily
Certoparin Renal
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.
Intervention: Certoparin 3,000 IU Twice a Day
Certoparin Renal
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.
Intervention: Certoparin 8,000 IU Once Daily
Certoparin Renal
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.
Intervention: Certoparin 8,000 IU Twice a Day
Outcomes
Primary Outcomes
Plasma aXa-Profile: C0
Time Frame: 5 days
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.
Dose regimen, systemic total exposure to aXa (AUC0-τ,ss)
Time Frame: 5 days
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.
Plasma aXa-Profile: Cmax
Time Frame: 5 days
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.
Plasma aXa-Profile: AUC
Time Frame: 5 days
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.