A Study in Healthy People to Test Whether Different Doses of BI 1015550 Have Potential to Induce Heart Rhythm Abnormalities

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 1015550; Drug: Placebo; Drug: Moxifloxacin

• Registration Number: NCT06107036
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The main objective of this trial is to evaluate the effects of a single therapeutic and a single supra-therapeutic dose of BI 1015550 following oral administration on cardiac safety parameters in healthy male and female volunteers.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-24
• Study First Submitted QC: 2023-10-24
• Study First Posted: 2023-10-30
• Study Start: 2024-03-04
• Primary Completion: 2024-07-25
• Study Completion: 2024-07-25
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

1. 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) and pulse rate (PR), 12-lead electrocardiogram (ECG), and clinical laboratory tests without any clinically significant abnormalities

2. Age of 18 to 50 years (inclusive)

3. Body mass index of 18.5 to 32 kg/m^2 (inclusive)

4. 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

5. Either male subjects, or female subjects meet the following criteria requiring highly effective contraception from at least 30 days before the first administration of trial medication until 37 days after the last administration of the study drug:

   • Male participants must use condom plus their partner, if identified as a women of childbearing potential (WOCBP), must use an oral contraceptive or highly effective contraception
   • Female participants must be using highly effective contraception and in addition their male partner must use a condom if they are using an oral contraceptive

Exclusion Criteria

1. Any finding in the medical examination (including BP, Heart rate (HR) 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 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or heart rate outside the range of 50 to 90 beats per minute (bpm)
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, in particular, hepatic parameters (alanine transaminase, aspartate transaminase, total bilirubin) or renal parameters (creatinine) exceeding the upper limit of normal
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders assessed as clinically relevant by the investigator
6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
7. 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 behaviour
8. History of clinically relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment 1 (L - low)	BI 1015550	Treatment with low dose BI 1015550
Treatment 4 (P1 and P2 - placebo)	Placebo	Treatment with placebo matching BI 105550 in two different periods: P1 and P2
Treatment 1 (L - low)	Placebo	Treatment with low dose BI 1015550
Treatment 2 (H - high)	BI 1015550	High dose treatment with BI 1015550
Treatment 3 (M - moxifloxacin)	Moxifloxacin	Treatment with moxifloxacin

Primary Outcome Measures

Name	Time	Method
Maximum mean difference between each single dose of BI 1015550 and placebo in QTcF changes from baseline between 20 min to 24 hours after drug administration	Up to 24 hours	QT interval corrected for heart rate, e.g. using the method of Fridericia (QTcF)

Secondary Outcome Measures

Name	Time	Method
Maximum mean difference between moxifloxacin and placebo in QTcF changes from baseline between 20 min to 24 hours after drug administration	Up to 24 hours	QT interval corrected for heart rate, e.g. using the method of Fridericia (QTcF)

Trial Locations

Locations (1)

Quotient Sciences; 🇬🇧 Nottingham, United Kingdom