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NCT06393127 | Not yet recruiting | Healthy

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

Condition or disease

Healthy

Intervention/treatment

BI 1015550 Formulation C2

BI 1015550 Formulation C1 (R) then BI 1015550 Formulation C2 (T)

Phase

Phase 1

Study Type : Interventional
Estimated Enrollment : 64 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : Bioequivalence of the BI 1015550 High Dose Formulation C2 and the BI 1015550 High Dose Formulation C1 (Phase 3 Formulation) Following Oral Administration in Healthy Subjects (an Open-label, Randomised, Single-dose, Two-way Crossover Trial)
Actual Study Start Date : May 7, 2024
Estimated Primary Completion Date : August 30, 2024
Estimated Study Completion Date : August 30, 2024
Arm Intervention/treatment

Experimental: BI 1015550 Formulation C2 (T) then BI 1015550 Formulation C1 (R)

Drug: BI 1015550 Formulation C2

Drug: BI 1015550 Formulation C1 (R) then BI 1015550 Formulation C2 (T)

Experimental: BI 1015550 Formulation C1 (R) then BI 1015550 Formulation C2 (T)

Drug: BI 1015550 Formulation C2

Drug: BI 1015550 Formulation C1 (R) then BI 1015550 Formulation C2 (T)
Ages Eligible for Study: 18 Years to 50 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
Inclusion Criteria
  • 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
  • Age of 18 to 50 years (inclusive)
  • Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
  • 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
  • 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 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
  • 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 Further exclusion criteria apply
A Study in Healthy People to Compare How 2 Different High Dose Formulations of BI 1015550 Are Taken up in the Body

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

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