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CompletedNCT07100964Updated Oct 14, 2025

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

A Phase 1 interventional study of nerandomilast and carbamazepine in Healthy, sponsored by Boehringer Ingelheim. Completed at 1 site in Germany. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-14.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
Male
01

Study summary

The main objective of this trial is to investigate the effect of carbamazepine on pharmacokinetics of nerandomilast.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy male trial participant according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), body weight, 12-lead electrocardiogram (ECG), and clinical laboratory tests
  2. Age of 18 to 55 years (inclusive)
  3. Body Mass Index (BMI) of 18.5 to 29.9 kg/ m\^2 (inclusive)
  4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
  5. If sexually active, sexual abstinence or use of a condom for at least 2 weeks after the last administration of carbamazepine.

Exclusion criteria

Exclusion Criteria :

  1. Any finding in the medical examination (including Blood pressure (BP), Pulse rate (PR) or ECG, 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 (PR) outside the range of 50 to 90 bpm
  3. Any evidence of a concomitant disease assessed as clinically relevant by the investigator
  4. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, haematological, neurological, psychiatric or hormonal disorders assessed as clinically relevant by the investigator
  5. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
  6. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders including but not limited to depression and suicidal behaviour
  7. History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Nerandomilast alone followed by nerandomilast + carbamazepine

    Drug: nerandomilast · Drug: carbamazepine

Interventions

  • Drugnerandomilast

    nerandomilast

    Also known as: JASCAYD®

  • Drugcarbamazepine

    carbamazepine

06

What researchers measure

Primary outcomes

  1. Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz)

    Time frame: Up to 30 days

  2. Maximum measured concentration of the analyte in plasma (Cmax)

    Time frame: Up to 30 days

Secondary outcomes

  1. Area under the Plasma Concentration Curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞)

    Time frame: Up to 30 days

07

Study locations

1 site
  • CRS Clinical Research Services Mannheim GmbH
    Mannheim, 68167, Germany
08

References and documents

Related links

Individual participant data

Plan to share: No — Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07100964
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Aug 3, 2025
Start date
Aug 11, 2025
Primary completion
Sep 20, 2025
Completion
Oct 1, 2025
Last update
Oct 14, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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