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

Study at a glance

From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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

ClinicalTrials.gov ID

NCT06107036

Acronym / sponsor ID

1305-0026

Conditions

Healthy

Phase

Phase 1

Study type

Interventional

Recruitment status

Completed

Enrolment

46 participants (actual)

Lead sponsor

Boehringer IngelheimIndustry (pharma, biotech, devices)

Study start

6 Mar 2024 (actual)

Primary completion

25 Jul 2024 (actual)

Study completion

25 Jul 2024 (actual)

First posted

30 Oct 2023 (actual)

Results

Posted 28 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Randomised

Intervention model

Crossover

Masking

Double blind (participant, investigator)

Number of arms

15

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.

Who may qualify

Ages

18 to 50 years

Sex

All

Healthy volunteers

Accepted

Age groups

Adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. The Maximum Mean Difference Between Each Single Dose of Either a Low Dose or a High Dose of Nerandomilast and Placebo in QTcF Changes From Baseline Between 20 Min to 24 Hours After Drug Administration

   Time frame: MMRM included measurements at these time points [hours:minutes] post-drug: 0:20, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 4:30, 5:00, 6:00, 8:00, 12:00, and 24:00. MMRM values at 12:00 (low dose) and 4:30 (high dose) are shown in the table below.

   QT interval corrected for heart rate (using the method of Fridericia, QTcF) changes from baseline, measured between 20 minutes and 24 hours after drug administration, were analyzed using a linear Mixed Model for Repeated Measures (MMRM). Pairwise comparison was used to compare the QTcF changes for each dose of nerandomilast (e.g., low dose, high dose) with the placebo at every time point. Mean treatment differences in the QTcF changes from baseline at each time point were estimated by the differences in the corresponding least-squares means. Two-sided 90% confidence intervals based on the t-distribution were computed for each time point. The MMRM was adjusted for the discrete fixed effects treatment, period, time, the continuous fixed effects period- and participant-baseline, the fixed effect-by-time terms, participant as random effect and time within period as a repeated effect per participant. The covariance structure for the repeated effect time was unstructured.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Related InfoLink provided by the sponsor.
• Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.