NCT01504165

Pharmacokinetics in Subjects With Renal Impairment

A Phase I, Open-label, Parallel-group, Mono-center Trial to Investigate the Pharmacokinetics of a Single Intravenous Dose of Cilengitide in Subjects With Mild, Moderate or Severe Renal Impairment Compared to Subjects With Normal Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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 grades of renal impairment as compared to subjects with normal renal function.

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 and assigned to one of the stratification groups defined below: Group Number/Renal function/Creatinine Clearance (GFR according to MDRD) 1. Normal renal function (≥ 90 mL/min) 2. Mild renal impairment (60 - 89 mL/min) 3. Moderate renal impairment (30 - 59 mL/ min) 4a: Severe renal impairment (\< 30 mL/min) - no dialysis required 4b: (if applicable) Severe renal impairment (\< 30 mL/min) - no dialysis required Subjects in Groups 2 and 3 will receive a single dose of 2000mg of cilengitide as 1-hour i.v. infusion. Subjects from group 4a will receive a single dose of 1000mg of cilengitide as 1-hour i.v. infusion . PK samples will be collected and basic PK parameters will be calculated. The safety, tolerability, and PK will be evaluated by the Safety Monitoring Committee (SMC). If the SMC has no concerns, Group 4b will be treated with a higher dose (up to 2000mg) of cilengitide. Then, Group 1 (healthy subjects) will be started after the last subject with renal impairment (in either Group 2, 3, or 4a; or in Group 4b, if applicable) has completed all activities on Day 3. They will also receive a single dose of 2000mg of cilengitide as 1-hour i.v. infusion. The duration of the trial from the first subject enrolled to the last subject last visit will be approximately 6 months (approximately 8 months, in case Group 4b is included). Each subject will participate in the trial for up to 35 days, including screening and the end of trial examination.

Conditions

• Renal Impairment

Interventions

Type	Name	Description
DRUG	cilengitide 2000mg	A single dose of cilengitide 2000mg (250mL) will be administered as 1-hour i.v. infusion on Day 1
DRUG	cilengitide 2000mg	A single dose of cilengitide 2000mg (250mL) will be administered as 1-hour i.v. infusion on Day 1
DRUG	cilengitide 2000mg	A single dose of cilengitide 2000mg (250mL) will be administered as 1-hour i.v. infusion on Day 1
DRUG	cilengitide 1000mg	A single dose of cilengitide 1000mg (125mL) will be administered as 1-hour i.v. infusion on Day 1
DRUG	cilengitide > 1000mg and up to 2000mg	A single dose of cilengitide \> 1000mg and up to 2000mg will be administered as 1-hour i.v. infusion on Day 1 if applicable, based on Safety Monitoring Committee decision

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2012-01-05
• Last updated: 2014-02-04

Locations

2 sites across 1 country: Germany