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Pharmacokinetics in Subjects With Renal Impairment

NCT01504165 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2014-02-04

No results posted yet for this study

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.

Conditions

  • Renal Impairment

Interventions

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

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Andreas Becker, MD MSc · Merck Serono S.A., Geneva

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01504165 on ClinicalTrials.gov