KF2022#4-trial: Effects of a Beta Blocker and NSAID on CYP Mediated Drug Metabolism

Launched by HELSINKI UNIVERSITY CENTRAL HOSPITAL · Aug 20, 2024

Keywords

ClinConnect Summary

The KF2022#4 trial is studying how two common medications, carvedilol (a beta-blocker used for heart conditions) and diclofenac (an anti-inflammatory drug), affect how the body processes other drugs. Researchers have found that both medications can interfere with certain liver enzymes that help break down various medications. This could lead to unwanted side effects if someone is taking other drugs that rely on these enzymes. In this study, healthy volunteers will take a combination of these medications alongside a low-dose model drug, and their blood will be tested to see how these drugs interact over time.

To join the study, participants need to be between 18 and 40 years old, healthy, and meet specific health criteria, such as having normal blood pressure and heart rate. They should not have any significant health issues or be taking regular medications. If selected, participants can expect to take the medications in a controlled setting, provide blood samples, and monitor how their bodies respond to the drugs for up to 23 hours. It's important to know that this trial is not yet recruiting participants, so there will be more information available as it progresses.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Written informed consent
• • Age 18-40
• • Healthy
• • Systolic blood pressure ≥110 mmHg
• • Heart rate ≥ 55/min
• • Normal ECG
• • Accepted results from laboratory tests (blood haemoglobin, basic blood count and blood platelets, alanine aminotransferase, alkaline phosphatase, glutamyl transferase, creatine kinase, creatinine, plasma glucose concentration, plasma potassium and sodium). Negative pregnancy test result (serum human chorionic gonadotropin) for women.
• Exclusion Criteria:
• • Significant disease
• • Previous or current gastrointestinal bleeding, ulcer or perforation
• • Findings of a medical examination and laboratory tests, which require a more detailed examination of the state of health
• • Smoking
• • Hormonal birth control or other regular medication
• • Pregnancy (current or planned) or nursing
• • Participation in any other studies involving investigational or marketed drug products within three months prior to the entry into this study
• • Donation of blood within three months prior to the entry into this study
• • Significant overweight / small or hard-to-find veins
• • BMI \< 18.5 kg/m2
• • Insufficient Finnish language skills
• • Hypersensitivity or contraindication to study drugs