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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 1015550 Formulation C2; Drug: BI 1015550 Formulation C1

• Registration Number: NCT06393127
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-29
• Study First Submitted QC: 2024-04-29
• Study First Posted: 2024-05-01
• Study Start: 2024-05-23
• Primary Completion: 2024-09-13
• Study Completion: 2024-09-13
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BI 1015550 Formulation C2 (T) then BI 1015550 Formulation C1 (R)	BI 1015550 Formulation C2	-
BI 1015550 Formulation C2 (T) then BI 1015550 Formulation C1 (R)	BI 1015550 Formulation C1	-
BI 1015550 Formulation C1 (R) then BI 1015550 Formulation C2 (T)	BI 1015550 Formulation C2	-
BI 1015550 Formulation C1 (R) then BI 1015550 Formulation C2 (T)	BI 1015550 Formulation C1	-

Primary Outcome Measures

Name	Time	Method
Maximum measured concentration of the analyte in plasma (Cmax)	up to 7 days.
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)	up to 7 days.

Secondary Outcome Measures

Name	Time	Method
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)	up to 7 days.

Trial Locations

Locations (1)

Charité Research Organisation GmbH; 🇩🇪 Berlin, Germany