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A Study to Assess the Effect of Ceftobiprole on the PK of Pitavastatin and on Plasma Levels of Coproporphyrin

NCT06808646 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-04-21

Study results available
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Summary

The goal of this clinical study was to determine the effect of the test drug ceftobiprole (a drug approved for the treatment of bacterial infections) on the elimination of pitavastatin (a drug approved for the treatment of increased levels of cholesterol in blood) from the body. This interaction was investigated by pharmacokinetic (PK) assessments. The clinical study also investigated the safety of ceftobiprole and how well ceftobiprole was tolerated by healthy subjects when it was administered in combination with pitavastatin.

Conditions

  • Drug-drug Interaction Study

Interventions

DRUG

pitavastatin

Single oral administration

DRUG

pitavastatin single dose combined with ceftobiprole

Single oral pitavastatin co-administered with IV ceftobiprole

Sponsors & Collaborators

Principal Investigators

  • Thomas Kaindl, MD · Basilea Pharmaceutica International Ltd, Allschwil

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2025-01-17
Primary Completion
2025-02-25
Completion
2025-02-25
FDA Drug
Yes

Countries

  • Netherlands

Study Locations

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Entities

Companies

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 NCT06808646 on ClinicalTrials.gov