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NCT Number: NCT07781631

A Study in Healthy Men to Test Whether Carbamazepine Influences the Amount of Verducatib in the Blood

The main objective of this trial is to investigate the effect of carbamazepine, a strong CYP3A4 inducer on the pharmacokinetics of verducatib at steady state.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

CRS Clinical Research Services Berlin GmbH

Berlin, 13627, Germany

Location status: Recruiting

Location contact

Boehringer Ingelheim

CONTACT

[email protected]

08007234742

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • Age of 18 to 50 years, inclusive
  • Body mass index (BMI) of 18.5 to 29.9 kg/m2, inclusive
  • 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

  • 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
  • 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
  • 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
  • Any evidence of a concomitant disease assessed as clinically relevant by the Investigator
  • Further exclusion criteria apply

Treatment and study plan

Verducatib

Drug

Verducatib

Other names: BI 1291583

carbamazepine

Drug

Carbamazepine

Primary outcomes

  1. Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)

    Time frame: Up to 40 days.

  2. Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss)

    Time frame: Up to 40 days.

Secondary outcomes

  1. Minimum concentration of the analyte in plasma at steady state within a uniform dosing interval τ (Cmin,ss)

    Time frame: Up to 40 days.

Study contacts

Contact information is provided by the study sponsor or research team.

Boehringer Ingelheim

CONTACT

[email protected]

1-800-243-0127

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

An Open-label, Fixed-sequence, Two-period Phase I Trial to Evaluate the Effect of Multiple Oral Doses of Carbamazepine, a Strong CYP3A4 Inducer, on the Pharmacokinetics of Verducatib at Steady State in Healthy Male Trial Participants

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 24, 2026
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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