A study in healthy people to compare 2 different formulations of nerandomilast tablets when taken with or without food

Phase 1

• Conditions: Healthy volunteer trial; Therapeutic area: Not possible to specify

• Registration Number: CTIS2024-511245-18-00
• Lead Sponsor: Boehringer Ingelheim International GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-10
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• 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 (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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified