A Study in Healthy People to Compare How 2 Different High Dose Formulations of BI 1015550 Are Taken up in the Body

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Nerandomilast

Study type: Interventional

Funder types: Industry

Identifiers

NCT06393127

2023-509950-67-00 (Registry Identifier)

1305-0037

U1111-1301-0834 (Registry Identifier)

Details and patient eligibility

About

The main objective of this trial is to establish the bioequivalence of the BI 1015550 Formulation C2 (Test, T) and the BI 1015550 Formulation C1 (Reference, R), following a single oral dose administration.

Enrollment: 64 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male or female subject 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
2. Age of 18 to 50 years (inclusive)
3. Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
4. Signed and dated written informed consent in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial Further inclusion criteria apply.

Exclusion criteria

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm) at screening
3. 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
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Test treatment (T), then reference treatment (R): T-R

Experimental group

Description:

Healthy subjects were administered one tablet of nerandomilast (Formulation C2) (Test treatment - T). After a washout period of at least 10 days, subjects were administered one tablet of nerandomilast (Formulation C1 - phase 3 formulation) (Reference treatment - R). Both treatments were administered orally with approximately 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h). After drug administration, subjects additionally fasted for 4 h.

Treatment:

Drug: Nerandomilast

Drug: Nerandomilast

Reference treatment (R), then test treatment (T): R-T

Experimental group

Description:

Healthy subjects were administered one tablet of nerandomilast (Formulation C1 - phase 3 formulation) (Reference treatment - R). After a washout period of at least 10 days, subjects were administered one tablet of nerandomilast (Formulation C2) (Test treatment - T). Both treatments were administered orally with approximately 240 mL of water after an overnight fast of at least 10 h. After drug administration, subjects additionally fasted for 4 h.

Treatment:

Drug: Nerandomilast

Drug: Nerandomilast