NCT06107036|CompletedPhase 1Results

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

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

Boehringer Ingelheim ClinicalTrials.gov

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2 other identifiers

1305-0026U1111-1295-4664

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredOct 2023

StartedMar 2024

CompletionJul 2024

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline

Completed

Started Mar 2024

Typical duration for phase_1 healthy

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5 months study duration

First Submitted

Initial submission to the registry

October 24, 2023

Completed

6 days until next milestone

First Posted

Study publicly available on registry

October 30, 2023

Completed

4 months until next milestone

Study Start

First participant enrolled

March 6, 2024

Completed

5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2024

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2024

Completed

1.3 years until next milestone

Results Posted

Study results publicly available

November 28, 2025

Completed

Last Updated

November 28, 2025

Status Verified

October 1, 2025

Enrollment Period

5 months

First QC Date

October 24, 2023

Results QC Date

November 14, 2025

Last Update Submit

November 14, 2025

Conditions

Healthy

Outcome Measures

Primary Outcomes (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
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.
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.

Secondary Outcomes (1)

The Maximum Mean Difference Between Moxifloxacin and Placebo in QTcF Changes From Baseline Between 20 Min to 24 Hours After Drug Administration.
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 3:30 (high dose moxifloxacin) are shown in the table below.

Study Arms (15)

Sequence 1: H/M/P2/L/P1

EXPERIMENTAL

Participants in this study received five treatments in the order described below. Each treatment was administered orally with 240 mL of water following an overnight fast of at least 10 hours. A washout period of at least 7 days separated each treatment. H (high-dose nerandomilast): Participants received film-coated tablets containing a high dose of nerandomilast. M (high-dose moxifloxacin - Positive Control): Participants received film-coated tablets containing a high dose of moxifloxacin as a positive control. P2 (Placebo 2): Participants received placebo tablets designed to match the high-dose nerandomilast group. L (low-dose nerandomilast): Participants received film-coated tablets containing a low dose of nerandomilast. P1 (Placebo 1): Participants received placebo tablets designed to match the low-dose nerandomilast group.