Healthy men test drug interaction in Early-Stage study
NCT ID NCT07100964
First seen Jun 27, 2026 ยท Last updated Jun 27, 2026
Summary
This study looked at how taking multiple doses of carbamazepine changes the way the body processes a single dose of nerandomilast. Sixteen healthy men aged 18 to 55 took part. The goal was to measure drug levels in the blood, not to treat any disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
16 people
The number who actually took part.
- Started
-
Aug 2025
- Finished
-
Oct 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
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Male participants only
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 7. History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
CRS Clinical Research Services Mannheim GmbH
Mannheim, 68167, Germany
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