A Study in Healthy People to Test How BI 1015550 is Taken up in the Body When Given With or Without Food

NCT ID: NCT06415045

Last Updated: 2025-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-28
• Study Completion Date: 2024-07-24

Brief Summary

The main objective is to investigate the effect of food on the pharmacokinetics of BI 1015550 Formulation C2.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nerandomilast fasted state (Reference (R))/Nerandomilast fed state Test (T)

Nerandomilast fasted state Reference (R)/Nerandomilast fed state Test (T)

Two period crossover separated by a wash-out of at least 10 days:

Period 1: Participants received one 18 mg Nerandomilast Formulation C2 film-coated tablet following an overnight fast of at least 10 hours.

Period 2: Participants received One 18 mg Nerandomilast Formulation C2 film-coated tablet following a high fat/high calorie meal.

Group Type: EXPERIMENTAL

BI 1015550

Intervention Type: DRUG

Participants received a single 18 mg Nerandomilast Formulation C2 film-coated tablet either after an overnight fast of at least 10 hours or following a high-fat, high-calorie meal.

Nerandomilast fed state (Test (T))/Nerandomilast fasted state (Reference (R))

Nerandomilast fed state Test (T)/Nerandomilast fasted state Reference (R)

Two period crossover separated by a wash-out of at least 10 days:

Period 1: Participants received One 18 mg Nerandomilast Formulation C2 film-coated tablet following a high fat/high calorie meal.

Period 2: Participants received one 18 mg Nerandomilast Formulation C2 film-coated tablet following an overnight fast of at least 10 hours.

Group Type: EXPERIMENTAL

BI 1015550

Intervention Type: DRUG

Participants received a single 18 mg Nerandomilast Formulation C2 film-coated tablet either after an overnight fast of at least 10 hours or following a high-fat, high-calorie meal.

Interventions

BI 1015550

Participants received a single 18 mg Nerandomilast Formulation C2 film-coated tablet either after an overnight fast of at least 10 hours or following a high-fat, high-calorie meal.

Intervention Type: DRUG

Other Intervention Names

Nerandomilast; JASCAYD®

Eligibility Criteria

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 50 years (inclusive)
• Body mass index (BMI) of 18.5 to 29.9 kg/m^2 (inclusive)
• Signed and dated written informed consent in accordance with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
• Female subject who meets the criteria defined in the protocol for a highly effective contraception from at least 30 days before the first administration of trial medication until 7 days after last administration

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 50 to 90 betas per minute (bpm) at screening
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, in particular, hepatic parameters (Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), total bilirubin) or renal parameters (creatinine) exceeding the upper limit of normal (ULN) at screening
• Any evidence of a concomitant disease assessed as clinically relevant by the investigator
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders assessed as clinically relevant by the investigator
• Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
• 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 behavior

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CRS Clinical Research Services Berlin GmbH

Berlin, , Germany

Countries

Germany

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.mystudywindow.com

Related Info

Other Identifiers

2023-509889-38-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1301-0891

Identifier Type: OTHER

Identifier Source: secondary_id

1305-0039

Identifier Type: -

Identifier Source: org_study_id