NCT06808646

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

A Phase 1, Single-center, Open-label, Non-randomized, Fixed-sequence, Drug-drug Interaction Study to Assess the Effect of Repeated Doses of Intravenous Ceftobiprole on the Pharmacokinetics of Oral Pitavastatin (OATP1B Substrate) and on Plasma Levels of Coproporphyrin I (OATP1B Biomarker) in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Basilea Pharmaceutica · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical study is 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 will be investigated by pharmacokinetic (PK) assessments. The PK of pitavastatin will be assessed when administered alone and when administered together with ceftobiprole in a study design including two treatment periods. The clinical study will also investigate the safety of ceftobiprole and how well ceftobiprole is tolerated by healthy subjects when it is administered in combination with pitavastatin. In addition, the effect of ceftobiprole on a specific marker, called coproporphyrin I, will be assessed in the blood. The duration of the study will be a maximum of 38 days.

Conditions

• Drug-drug Interaction Study

Interventions

Type	Name	Description
DRUG	pitavastatin	Single oral administration
DRUG	pitavastatin single dose combined with ceftobiprole	Single oral pitavastatin co-administered with IV ceftobiprole

Timeline

• Start date: 2025-01-17
• Primary completion: 2025-02-25
• Completion: 2025-02-25
• First posted: 2025-02-05
• Last updated: 2025-04-01

Locations

1 site across 1 country: Netherlands

Regulatory

• FDA-regulated drug study