Pharmacokinetics of Certoparin in Subjects With Renal Insufficiency and Healthy Subjects

Phase 2CompletedNCT01660295

Novartis Pharmaceuticals32 enrolled

Overview

This study will assess the pharmacokinetics in subjects with severe renal insufficiency and healthy subjects.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Renal Insufficiency

Interventions

Certoparin 3,000 IU Once DailyDRUG

Certoparin 3,000 IU subcutaneous injection once daily

Certoparin 3,000 IU Twice a DayDRUG

Certoparin 3,000 IU subcutaneous injection twice a day

Certoparin 8,000 IU Once DailyDRUG

Certoparin 8,000 IU subcutaneous injection once daily

Eligibility

Sex: ALLMin age: 21 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

DRC Drug Research Center Ltd., H-8230 Balatonfüred

H-8230 Balatonfüred, Ady E. U., Hungary

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 5 days

Data from ClinicalTrials.gov

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