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

NCT07781631 | Not Yet Recruiting Phase 1

• 1 other identifier: 1397-0044
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

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

  Up to 40 days.

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

  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)

  Up to 40 days.

Study Arms (1)

Verducatib, then verducatib + carbamazepine

EXPERIMENTAL

Fixed-sequence treatment for all trial participants.

Drug: Verducatib; Drug: Carbamazepine

Interventions

Verducatib DRUG

Verducatib

Also known as: BI 1291583

Verducatib, then verducatib + carbamazepine

Carbamazepine DRUG

Carbamazepine

Verducatib, then verducatib + carbamazepine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

CRS Clinical Research Services Berlin GmbH

Berlin, 13627, Germany

Location

Related Links

• Related Info

MeSH Terms

Interventions

Carbamazepine

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Boehringer Ingelheim

CONTACT

1-800-243-0127; clintriage.rdg@boehringer-ingelheim.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants receive verducatib in the treatment period 1 and continue for the treatment period 2 to receive verducatib and carbamazepine.

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 24, 2026
• Study Start (Estimated): September 10, 2026
• Primary Completion (Estimated): December 14, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)