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

Last updated: February 17, 2025
Sponsor: Boehringer Ingelheim
Overall Status: Completed

Phase

1

Condition

N/A

Treatment

Nerandomilast, Formulation 2

Nerandomilast, Formulation 1

Clinical Study ID

NCT06624072
1305-0029
2024-511245-18-00
U1111-1304-2287
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthy male or female subjects according to the assessment of the investigator, asbased on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), andclinical 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 locallegislation prior to admission to the trial Further inclusion criteria apply.

Exclusion

Exclusion Criteria:

  • Any finding in the medical examination (including BP, PR or ECG) deviating fromnormal 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 outsidethe range of 45 to 90 beats per minute (bpm)

  • Any laboratory value outside the reference range that the investigator considers tobe of clinical relevance

  • Any evidence of a concomitant disease assessed as clinically relevant by theinvestigator Further exclusion criteria apply.

Study Design

Total Participants: 15
Treatment Group(s): 2
Primary Treatment: Nerandomilast, Formulation 2
Phase: 1
Study Start date:
October 15, 2024
Estimated Completion Date:
November 30, 2024

Connect with a study center

  • Humanpharmakologisches Zentrum Biberach

    Biberach, 88397
    Germany

    Site Not Available

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