2024-511245-18-00CompletedPhase 1
Relative bioavailability of two different formulations of nerandomilast and investigation of the food effect on new formulation following oral administration in healthy adult male and female subjects (an open-label, randomised, single-dose, three-way crossover trial)
Boehringer Ingelheim International GmbH1 site in 1 country15 target enrollmentStarted: August 8, 2024Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
Study Overview
Brief Summary
The main objective of this trial is to investigate two different formulations of nerandomilast and the effect of food on the PK of the new formulation following oral administration.
Eligibility Criteria
- Ages
- 18 years to 64 years (18-64 Years)
- Accepts Healthy Volunteers
- Yes
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 (BP, PR), 12-lead ECG, and clinical laboratory tests
- •Age of 18 to 55 years (inclusive)
- •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.
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 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.
Outcomes
Primary Outcomes
AUC0-tz (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 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
Cmax (maximum measured concentration of the analyte in plasma)
Cmax (maximum measured concentration of the analyte in plasma)
Secondary Outcomes
- AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Investigators
CT Disclosure & Data Transparency
Scientific
Boehringer Ingelheim International GmbH
Study Sites (1)
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