Clinical trial NCT06107036: A Study in Healthy People to Test Whether Different Doses of BI 1015550 Have Potential to Induce Heart Rhythm Abnormalities
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2023-10-30
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Up to 24 hours
Secondary outcomes:
measure: Maximum mean difference between moxifloxacin and placebo in QTcF changes from baseline between 20 min to 24 hours after drug administration
timeFrame: Up to 24 hours
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient Sciences
Study officials:
References: