Carbamazepine and Verducatib: How the Drug Interaction Might Change Blood Levels in Healthy Men

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 trial in healthy male volunteers explores the effect of carbamazepine, a strong inducer of the CYP3A4 enzyme, on the pharmacokinetics of verducatib when steady-state levels are reached. Participants receive verducatib and carbamazepine to see how the two drugs interact in the body. The study uses standard clinical assessments and safety monitoring to determine blood levels and tolerability. Conducted at CRS Clinical Research Services Berlin under Boehringer Ingelheim as lead sponsor, the trial emphasizes safety and pharmacokinetic outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Healthy male trial participant according to the assessment of the Investigator, as based on a complete medical history including physical examination, vital signs (blood pressure, heart rate), 12-lead electrocardiogram, clinical laboratory tests and columbia-suicide severity rating scale (C-SSRS)
2. Age of 18 to 50 years, inclusive
3. Body mass index (BMI) of 18.5 to 29.9 kg/m2, inclusive
4. Signed and dated written informed consent in accordance with international council for harmonisation-good clinical practice (ICH-GCP) and local legislation prior to admission to the trial

Exclusion Criteria:

1. Any finding in the medical examination, including blood pressure, pulse rate or electrocardiogram, as well as neurological examination and skin inspection deviating from normal and assessed as clinically relevant by the Investigator
2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute
3. Any laboratory value outside the reference range that the Investigator considers to be of clinical relevance, particularly including but not limited to haematological parameters such as haemoglobin, serum iron, leucocyte- and platelet count, hepatic parameters such as alanine aminotransferase (ALT), aspartate aminotransfrrase (AST), gamma-glutamyl transferase (GGT) and total bilirubin or renal parameters such as e.g. creatinine at screening, electrolyte disturbances, particularly hyponatremia
4. Any evidence of a concomitant disease assessed as clinically relevant by the Investigator
5. Further exclusion criteria apply

Where it's running

• CRS Clinical Research Services Berlin GmbH
  Berlin, Germany Recruiting

Study contacts

• Study coordinator: Boehringer Ingelheim
• Email: clintriage.rdg@boehringer-ingelheim.com
• Phone: 1-800-243-0127

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.