Evaluation of Penetration of Ceftobiprole Into Soft Tissue Determined by Microdialysis in Healthy Volunteers

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Basilea Pharmaceutica

Status and phase

Completed
Phase 1

Conditions

Streptococcal Infections
Staphylococcal Skin Infections

Treatments

Drug: Ceftobiprole

Study type

Interventional

Funder types

Industry

Identifiers

NCT01026740
CSI-1002 (Other Identifier)
CR011416

Details and patient eligibility

About

The primary objective of this study is to measure the penetration of ceftobiprole into subcutaneous (s.c.) adipose tissue and skeletal muscle and to determine the concentration over time of ceftobiprole in these tissues and in plasma after administration of a single intravenous (i.v.) infusion (directly into the vein) of ceftobiprole 500 mg administered over 2 hours. The secondary objective was to further assess the safety and tolerability of ceftobiprole after a single i.v. infusion.

Full description

This is a single-center, open-label (all patients involved know the identity of the drug), single-arm, nonrandomized study of ceftobiprole in healthy men and women. The study is conducted in 2 parts: a pilot study and a main study. Each study (i.e. the pilot study and the main study) consists of 3 phases: a pretreatment phase that includes up to a 21-day screening period, an open-label treatment phase (1 day in the pilot study and 2 days in the main study), and a posttreatment phase that included the end of study evaluations and follow-up study visit or telephone contact planned for 1 to 2 weeks after discharge from the study unit. Serial blood and dialysis samples will be collected at specified time points from predose through 24 hours after the start of the infusion for estimation of ceftobiprole and ceftobiprole medocaril concentrations. Additional samples will be collected for measurement of protein binding. The study will include the following evaluations of safety and tolerability: adverse events, clinical laboratory tests (including hematology, serum chemistry, and urinalysis), electrocardiogram (ECG), vital signs, physical examination, serology, pregnancy tests, urine drug screen, and alcohol breath test. In the pilot study, Ceftobiprole will be locally administered via a microdialysis probe at a concentration of approximately 30 µg/mL for 60 minutes. In the main Study, each volunteer will receive ceftobiprole locally via the microdialysis probe. After the washout period determined by the pilot study, each volunteer will receive a single 2-hour i.v. infusion of ceftobiprole.

Enrollment

15 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Body mass index (BMI between 18 to 29 kg/m2
  • Nonsmoker
  • Normal renal function

Exclusion criteria

  • History of gastric or duodenal ulcer
  • History of allergies or hypersensitivity (including penicillin, cephalosporins, or other ß-lactams or quinolones)
  • Hypersensitivity or intolerance to heparin
  • History of drug or alcohol abuse

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 1 patient group

001
Experimental group
Description:
Ceftobiprole 500 mg, single infusion over 2 hours
Treatment:
Drug: Ceftobiprole

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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