Status:
COMPLETED
Pharmacokinetics in Subjects With Renal Impairment
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Conditions:
Renal Impairment
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This is an open-label, non-randomized, parallel-group, mono-center, single intravenous dose, Phase I trial to investigate the Pharmacokinetic (PK) and safety of cilengitide in subjects with different ...
Detailed Description
Subjects with impaired renal function will be screened and will be stratified by their estimated glomerular filtration rate (GFR) according to the Modification of Diet in Renal Disease (MDRD) equation...
Eligibility Criteria
Inclusion
- \- Body mass index (BMI): ≥ 18 kg/m² and ≤ 35 kg/m²
- For subjects with normal renal function:
- Vital signs (pulse rate and blood pressure) within the normal range or showing no clinically relevant deviation
- Estimated creatinine clearance according to the MDRD equation of ≥ 90 mL/min at Screening
- For subjects with impaired renal function:
- Laboratory parameters should be within acceptable range for subjects with renal impairment,
- Vital signs: Pulse rate within the normal range of 45-100 beats/minute in supine position after 5 minutes of rest. Blood pressure diastolic below 100 mmHg, and systolic below 160 mmHg for Groups 1-3 and below 180 mmHg for Group 4a and 4b, in supine position after 5 minutes of rest
- Calculated creatinine clearance according to the MDRD equation of \< 90 mL/min at Screening and the possibility of stratification to one of the Groups.
Exclusion
- History of malignant disease within the last 5 years or acute malignant disease
- Medical history of wound healing problems and/or any current open wounds
- Current or history of bleeding disorders and/or history of thromboembolic events (considering family history as well); thrombolytics or oral or parenteral anticoagulants within 30 days prior to Day 1
- Electrocardiogram recording (12-lead ECG) with signs of clinically relevant pathology as judged by the Investigator
- For subjects with impaired renal function:
- Chronic heart failure non stabilized (New York Heart Association \[NYHA\] class III and IV)
- Acute renal failure of any etiology (including viral, toxic, or drug induced)
- Requiring dialysis
- History of renal transplantation
- Uncontrolled diabetes mellitus as judged by the Investigator
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01504165
Start Date
January 1 2012
End Date
April 1 2012
Last Update
February 4 2014
Active Locations (2)
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1
For Research Sites contact Merck KGaA Communication Center in
Darmstadt, Germany
2
CRS Clincial Research Services Kiel GmbH
Kiel, Germany