A Study in Healthy People to Compare 2 Different Formulations of Nerandomilast Tablets When Taken With or Without Food

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Nerandomilast, Formulation 1; Drug: Nerandomilast, Formulation 2

• Registration Number: NCT06624072
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The main objective of this trial is to investigate two different formulations of nerandomilast and the effect of food on the pharmakokinetics of the new formulation following oral administration.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-01
• Study First Submitted QC: 2024-10-01
• Study First Posted: 2024-10-02
• Study Start: 2024-10-15
• Primary Completion: 2024-11-22
• Study Completion: 2024-11-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Healthy male or female subjects 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)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
• Age of 18 to 55 years (inclusive)
• Body mass index (BMI) of 18.5 to 29.9 kg/m² (inclusive)
• Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial Further inclusion criteria apply.

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Exclusion Criteria

• Any finding in the medical examination (including BP, PR or ECG) 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 45 to 90 beats per minute (bpm)
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
• Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment sequence R-T1-T2	Nerandomilast, Formulation 1	-
Treatment sequence R-T1-T2	Nerandomilast, Formulation 2	-
Treatment sequence T1-T2-R	Nerandomilast, Formulation 1	-
Treatment sequence T1-T2-R	Nerandomilast, Formulation 2	-
Treatment sequence T2-R-T1	Nerandomilast, Formulation 1	-
Treatment sequence T2-R-T1	Nerandomilast, Formulation 2	-

Primary Outcome Measures

Name	Time	Method
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)	up to 5 days
Maximum measured concentration of the analyte in plasma (Cmax)	up to 5 days

Secondary Outcome Measures

Name	Time	Method
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)	up to 5 days

Trial Locations

Locations (1)

Humanpharmakologisches Zentrum Biberach; 🇩🇪 Biberach, Germany