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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-11

Study Completion Date

2025-10-01

Brief Summary

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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nerandomilast alone followed by nerandomilast + carbamazepine

Group Type EXPERIMENTAL

nerandomilast

Intervention Type DRUG

nerandomilast

carbamazepine

Intervention Type DRUG

carbamazepine

Interventions

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nerandomilast

Intervention Type DRUG

carbamazepine

Intervention Type DRUG

Other Intervention Names

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JASCAYD®

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes