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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 1015550

Study type: Interventional

Funder types: Industry

Identifiers

NCT06415045

U1111-1301-0891 (Other Identifier)

1305-0039

2023-509889-38-00 (Registry Identifier)

Details and patient eligibility

About

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

Enrollment: 18 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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
• History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Drug: BI 1015550

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

Experimental group

Description:

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.

Treatment:

Drug: BI 1015550