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

Sponsor

Boehringer Ingelheim (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06107036

Collaborator

(none)

Enrollment

Arms

4.6

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: BI 1015550 Drug: Moxifloxacin Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

This trial will be performed as a randomized, double-blind, 5-period crossover of BI 1015550 and moxifloxacin. Placebo will be given in two separate periods. There will be 15 treatment sequences based on a Prescott triple Latin square design for 5 treatments and 5 periods.This trial will be performed as a randomized, double-blind, 5-period crossover of BI 1015550 and moxifloxacin. Placebo will be given in two separate periods. There will be 15 treatment sequences based on a Prescott triple Latin square design for 5 treatments and 5 periods.

Masking:

Double (Participant, Investigator)

Masking Description:

The administration of BI 1015550 and placebo will be blinded while the administration of moxifloxacin will be carried out open label.

Primary Purpose:

Treatment

Official Title:

Thorough QT Study to Evaluate the Effects of BI 1015550 as Single Doses Following Oral Administration on Cardiac Safety Parameters (Double-blind, Randomized, Placebo-controlled, Five-period Crossover, With Open-label Moxifloxacin as Positive Control) in Healthy Male and Female Subjects

Anticipated Study Start Date :

Dec 13, 2023

Anticipated Primary Completion Date :

Apr 30, 2024

Anticipated Study Completion Date :

Apr 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment 1 (L - low) Treatment with low dose BI 1015550	Drug: BI 1015550 BI 1015550 Drug: Placebo Placebo-matching BI 101550
Experimental: Treatment 2 (H - high) High dose treatment with BI 1015550	Drug: BI 1015550 BI 1015550
Active Comparator: Treatment 3 (M - moxifloxacin) Treatment with moxifloxacin	Drug: Moxifloxacin Moxifloxacin Other Names: Avelox®
Placebo Comparator: Treatment 4 (P1 and P2 - placebo) Treatment with placebo matching BI 105550 in two different periods: P1 and P2	Drug: Placebo Placebo-matching BI 101550

Outcome Measures

Primary Outcome Measures

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

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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) and pulse rate (PR), 12-lead electrocardiogram (ECG), and clinical laboratory tests without any clinically significant abnormalities
Age of 18 to 50 years (inclusive)
Body mass index of 18.5 to 32 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
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:

Any finding in the medical examination (including BP, Heart rate (HR) 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 heart rate outside the range of 50 to 90 beats per minute (bpm)
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
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 behaviour
History of clinically relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Related Info

Publications

None provided.

Responsible Party:

Boehringer Ingelheim

ClinicalTrials.gov Identifier:

NCT06107036

Other Study ID Numbers:

1305-0026

First Posted:

Oct 30, 2023

Last Update Posted:

Nov 3, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Moxifloxacin

Study Results

No Results Posted as of Nov 3, 2023