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Antibiotic-Cholesterol drug interaction under the microscope
NCT ID NCT06808646
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This completed phase 1 study looked at whether the antibiotic ceftobiprole changes how the body handles the cholesterol drug pitavastatin. Twelve healthy adults received pitavastatin alone and then with ceftobiprole to compare drug levels in the blood. The goal is to see if combining these drugs requires dose adjustments for safety or effectiveness.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ceftobiprole (antibiotic) and pitavastatin (cholesterol drug)
- What this could lead to
- If successful, this study could help doctors understand whether ceftobiprole changes how other drugs are processed, leading to safer combination treatments.
- What could go wrong
- This is a very early, small study in healthy volunteers, not patients. It only tests one specific drug interaction, so results may not apply to other drugs or sicker people.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
12 people
The number who actually took part.
- Started
-
Jan 2025
- Finished
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Feb 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Main 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 were required not be pregnant or lactating and had to agree to use adequate contraception * Male subjects, if not surgically sterilized, were required to agree to use adequate contraception * All prescribed medication had to be stopped at least 30 days prior to admission to the clinical research center (an exception was made for hormonal contraceptives) * All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (e.g., St. John's wort) had to be 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 Main 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 had a history of seizures * Subject had 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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
ICON Early Clinical & Bioanalytical Solutions
Groningen, 9728, Netherlands
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