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

NCT ID: NCT06808646

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-17
• Study Completion Date: 2025-02-25

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Period 1; pitavastatin single dose, Period 2; pitavastatin single dose combined with ceftobiprole

Period 1 On Day 1, a single oral dose of pitavastatin will be administered

Period 2 From Day 4 to Day 7, ceftobiprole (as the prodrug ceftobiprole medocaril sodium) will be administered intravenously (IV) every 8 hours (q8h) for four days. On Day 6, a single oral dose of pitavastatin will be co-administered with ceftobiprole

Group Type: EXPERIMENTAL

pitavastatin

Intervention Type: DRUG

Single oral administration

pitavastatin single dose combined with ceftobiprole

Intervention Type: DRUG

Single oral pitavastatin co-administered with IV ceftobiprole

Interventions

pitavastatin

Single oral administration

Intervention Type: DRUG

pitavastatin single dose combined with ceftobiprole

Single oral pitavastatin co-administered with IV ceftobiprole

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Body mass index: 18.0 to 30.0 kg/m2, inclusive
• Good physical and mental health
• Normal renal function (creatinine clearance ≥ 90 mL/min as determined by the Cockcroft-Gault equation)
• Female participants of childbearing potential must not be pregnant or lactating and must must agree to use adequate contraception
• Male subjects, if not surgically sterilized, must agree to use adequate contraception
• All prescribed medication must have been stopped at least 30 days prior to admission to the clinical research center (an exception is made for hormonal contraceptives)
• All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (e.g., St. John's wort) must have been stopped at least 14 days prior to admission to the clinical research center
• Ability and willingness to abstain from alcohol from 48 hours (2 days) prior to Screening and admission to the clinical research center
• Ability and willingness to abstain from methylxanthine-containing beverages or food from 48 hours (2 days) prior to admission to the clinical research center

Exclusion Criteria

• History of relevant drug and/or food allergies, particularly to antibiotics.
• Subject received a known potent inhibitor of OATP1B activity within 30 days prior to admission
• Subject received a potential inducer of OATP1B activity within 30 days prior to admission
• Subject has a history of seizures
• Subject has a history of frequent diarrhea
• Smoking more than 5 cigarettes, 1 cigar, or 1 pipe daily; the use of tobacco products in the 48 hours (2 days) prior to admission
• History of alcohol abuse or drug addiction within 12 months prior to Screening.
• Average intake of more than 24 units of alcohol per week
• Positive drug and/or alcohol screen
• Donation or loss of more than 450 mL of blood within 60 days prior to the first pitavastatin administration on Day 1 of the current study. Donation or loss of more than 1.5 liters of blood (for male subjects)/more than 1.0 liters of blood (for female subjects) in the 10 months prior to the first pitavastatin administration on Day 1 of the current study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biomedical Advanced Research and Development Authority

FED

Sponsor Role: collaborator

Basilea Pharmaceutica

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Kaindl, MD

Role: STUDY_DIRECTOR

Basilea Pharmaceutica International Ltd, Allschwil

Locations

ICON Early Clinical & Bioanalytical Solutions

Groningen, , Netherlands

Countries

Netherlands

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

BPR-CP-101

Identifier Type: -

Identifier Source: org_study_id