Trial Outcomes & Findings for This Study in Healthy Men and Women Tests Whether BI 409306 Has an Effect on the ECG (Thorough QT Study) (NCT NCT03934203)

NCT ID: NCT03934203

Last Updated: 2024-03-12

Results Overview

QTcF is the QT interval (Electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) corrected using Fridericia's formula. Change from baseline in QTcF at that timepoint between 20 minutes to 24 hours after drug administration where the difference of means in QTcF changes from baseline between 50 mg BI 409306 and placebo takes its maximum. A linear mixed-effects model for repeated measurements based on Schall and Ring (MMRM) was fitted to the observations for 50 mg BI 409306 and the 2 placebo periods. Total number of participants per treatment and timepoint can be lower than 47 due to participants having left their treatment sequence before being exposed to the respective treatment, or due to exclusion of individual participant ECG data at timepoints affected by ECG-relevant important protocol deviations.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 47 participants
• Primary outcome timeframe: Baseline, 20 minutes (min), 40 min, 1 hour (h), 1 h 30 min, 2 h, 2 h 30 min, 3 h, 4 h, 8 h, 12 h, 24 h after study drug administration
• Results posted on: 2024-03-12

Participant Flow

This was a randomized, placebo-controlled, double-blind trial with crossover design with 5 treatment periods, 15 treatment sequences based on a balanced, Prescott triple Latin square design with a wash-out period of at least 6 days between treatments: 50 mg BI 409306, 250 mg BI 409306, 400 mg moxifloxacin (positive control, open-label), placebo (2 periods).

All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated. Abbreviation: mg=milligram. There was a washout period of at least 6 days between treatments.

Participant milestones

Measure	H/L/P/P/M Treatment Sequence In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2.	H/M/P/P/L Treatment Sequence In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2.	H/P/P/M/L Treatment Sequence In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2.	L/M/H/P/P Treatment Sequence In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2.	L/P/H/M/P Treatment Sequence In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2.	L/P/M/H/P Treatment Sequence In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2.	M/H/P/L/P Treatment Sequence In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2.	M/L/P/H/P Treatment Sequence In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2.	M/P/H/P/L Treatment Sequence In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2.	P/H/L/M/P Treatment Sequence In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2.	P/H/L/P/M Treatment Sequence In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2.	P/L/M/P/H Treatment Sequence In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2.	P/M/P/L/H Treatment Sequence In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2.	P/P/L/H/M Treatment Sequence In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2.	P/P/M/L/H Treatment Sequence In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2.
Overall Study STARTED	3	3	3	3	4	3	4	3	3	3	3	3	3	3	3
Overall Study COMPLETED	3	3	2	3	3	3	2	3	3	3	3	3	3	2	3
Overall Study NOT COMPLETED	0	0	1	0	1	0	2	0	0	0	0	0	0	1	0

Reasons for withdrawal

Measure	H/L/P/P/M Treatment Sequence In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2.	H/M/P/P/L Treatment Sequence In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2.	H/P/P/M/L Treatment Sequence In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2.	L/M/H/P/P Treatment Sequence In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2.	L/P/H/M/P Treatment Sequence In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2.	L/P/M/H/P Treatment Sequence In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2.	M/H/P/L/P Treatment Sequence In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2.	M/L/P/H/P Treatment Sequence In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2.	M/P/H/P/L Treatment Sequence In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2.	P/H/L/M/P Treatment Sequence In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2.	P/H/L/P/M Treatment Sequence In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2.	P/L/M/P/H Treatment Sequence In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2.	P/M/P/L/H Treatment Sequence In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2.	P/P/L/H/M Treatment Sequence In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2.	P/P/M/L/H Treatment Sequence In this randomized, placebo-controlled, 5-period crossover trial participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 mg BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations. L=50 mg BI 409306, H=250 mg BI 409306, M= 400 mg moxifloxacin, P=Placebo 1/Placebo 2.
Overall Study Adverse Event	0	0	1	0	1	0	2	0	0	0	0	0	0	1	0

Baseline Characteristics

This Study in Healthy Men and Women Tests Whether BI 409306 Has an Effect on the ECG (Thorough QT Study)

Baseline characteristics by cohort

Measure	Overall Study n=47 Participants Total number of participants randomized and treated in this randomized, placebo-controlled, 5-period crossover trial where participants were randomized to one of 15 possible treatment sequences based on a balanced, Prescott triple Latin square design. Treatments administered were 50 milligram (mg) BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets), 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets), 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet), Placebo 1 and Placebo 2 both administered orally as a single dose (5 film-coated tablets). In all treatment periods tablets were taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. The trial was double-blind for placebo and BI 409306, but open-label for moxifloxacin. A washout period of least 6 days was adhered to between drug administrations.
Age, Continuous	36.2 years STANDARD_DEVIATION 7.9 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	46 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 20 minutes (min), 40 min, 1 hour (h), 1 h 30 min, 2 h, 2 h 30 min, 3 h, 4 h, 8 h, 12 h, 24 h after study drug administration

Population: ECG Set: This participant set included all randomized participants who received at least one dose of any trial medication and who had at least one on-treatment value for at least one electrocardiogram (ECG) endpoint, which was not excluded due to ECG-relevant important protocol deviations (e.g. the use of pro-arrhythmic medications).

QTcF is the QT interval (Electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) corrected using Fridericia's formula. Change from baseline in QTcF at that timepoint between 20 minutes to 24 hours after drug administration where the difference of means in QTcF changes from baseline between 50 mg BI 409306 and placebo takes its maximum.

A linear mixed-effects model for repeated measurements based on Schall and Ring (MMRM) was fitted to the observations for 50 mg BI 409306 and the 2 placebo periods.

Total number of participants per treatment and timepoint can be lower than 47 due to participants having left their treatment sequence before being exposed to the respective treatment, or due to exclusion of individual participant ECG data at timepoints affected by ECG-relevant important protocol deviations.

Outcome measures

Measure	Placebo to BI 409306 in 2 Periods n=1000 Observations Placebo administered orally as a single dose (5 film-coated tablets) taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. Placebo was administered in two treatment periods.	50 Milligram (mg) BI 409306 n=493 Observations 50 milligram (mg) BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets) taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period.
Change From Baseline in QTcF at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in QTcF Changes From Baseline Between 50 Milligram (mg) BI 409306 and Placebo Takes Its Maximum 8 hours after drug intake	-7.0 milliseconds Standard Error 0.7	-7.3 milliseconds Standard Error 0.9
Change From Baseline in QTcF at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in QTcF Changes From Baseline Between 50 Milligram (mg) BI 409306 and Placebo Takes Its Maximum 20 min after drug intake=timepoint of maximum	-1.5 milliseconds Standard Error 0.4	-0.2 milliseconds Standard Error 0.6
Change From Baseline in QTcF at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in QTcF Changes From Baseline Between 50 Milligram (mg) BI 409306 and Placebo Takes Its Maximum 40 minutes after drug intake	-1.0 milliseconds Standard Error 0.4	-0.8 milliseconds Standard Error 0.6
Change From Baseline in QTcF at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in QTcF Changes From Baseline Between 50 Milligram (mg) BI 409306 and Placebo Takes Its Maximum 1 hour after drug intake	-0.5 milliseconds Standard Error 0.4	0.3 milliseconds Standard Error 0.6
Change From Baseline in QTcF at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in QTcF Changes From Baseline Between 50 Milligram (mg) BI 409306 and Placebo Takes Its Maximum 1 hour and 30 minutes after drug intake	-0.1 milliseconds Standard Error 0.5	-0.4 milliseconds Standard Error 0.7
Change From Baseline in QTcF at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in QTcF Changes From Baseline Between 50 Milligram (mg) BI 409306 and Placebo Takes Its Maximum 2 hours after drug intake	-0.1 milliseconds Standard Error 0.5	-0.3 milliseconds Standard Error 0.7
Change From Baseline in QTcF at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in QTcF Changes From Baseline Between 50 Milligram (mg) BI 409306 and Placebo Takes Its Maximum 2 hours and 30 minutes after drug intake	-2.0 milliseconds Standard Error 0.5	-1.7 milliseconds Standard Error 0.7
Change From Baseline in QTcF at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in QTcF Changes From Baseline Between 50 Milligram (mg) BI 409306 and Placebo Takes Its Maximum 3 hours after drug intake	0.4 milliseconds Standard Error 0.5	-0.2 milliseconds Standard Error 0.7
Change From Baseline in QTcF at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in QTcF Changes From Baseline Between 50 Milligram (mg) BI 409306 and Placebo Takes Its Maximum 4 hours after drug intake	1.0 milliseconds Standard Error 0.6	0.0 milliseconds Standard Error 0.8
Change From Baseline in QTcF at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in QTcF Changes From Baseline Between 50 Milligram (mg) BI 409306 and Placebo Takes Its Maximum 12 hours after drug intake	-1.0 milliseconds Standard Error 0.7	-1.0 milliseconds Standard Error 1.0
Change From Baseline in QTcF at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in QTcF Changes From Baseline Between 50 Milligram (mg) BI 409306 and Placebo Takes Its Maximum 24 hours after drug intake	-6.4 milliseconds Standard Error 0.6	-5.8 milliseconds Standard Error 0.8

PRIMARY outcome

Timeframe: Baseline, 20 minutes (min), 40 min, 1 hour (h), 1 h 30 min, 2 h, 2 h 30 min, 3 h, 4 h, 8 h, 12 h, 24 h after study drug administration

Population: ECG Set: This participant set included all randomized participants who received at least one dose of any trial medication and who had at least one on-treatment value for at least one electrocardiogram (ECG) endpoint, which was not excluded due to ECG-relevant important protocol deviations (e.g. the use of pro-arrhythmic medications).

QTcF is the QT interval (Electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) corrected using Fridericia's formula. Change from baseline in QTcF at that timepoint between 20 minutes to 24 hours after drug administration where the difference of means in QTcF changes from baseline between 250 mg BI 409306 and placebo takes its maximum.

A linear mixed-effects model for repeated measurements based on Schall and Ring (MMRM) was fitted to the observations for 250 mg BI 409306 and the 2 placebo periods.

Total number of participants per treatment and timepoint can be lower than 47 due to participants having left their treatment sequence before being exposed to the respective treatment, or due to exclusion of individual participant ECG data at timepoints affected by ECG-relevant important protocol deviations.

Outcome measures

Measure	Placebo to BI 409306 in 2 Periods n=1000 Observations Placebo administered orally as a single dose (5 film-coated tablets) taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. Placebo was administered in two treatment periods.	50 Milligram (mg) BI 409306 n=505 Observations 50 milligram (mg) BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets) taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period.
Change From Baseline in QTcF at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in QTcF Changes From Baseline Between 250 Milligram (mg) BI 409306 and Placebo Takes Its Maximum 20 minutes after drug intake	-1.4 milliseconds Standard Error 0.5	2.5 milliseconds Standard Error 0.6
Change From Baseline in QTcF at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in QTcF Changes From Baseline Between 250 Milligram (mg) BI 409306 and Placebo Takes Its Maximum 40 minutes after drug intake= timepoint of maximum	-1.0 milliseconds Standard Error 0.5	4.7 milliseconds Standard Error 0.7
Change From Baseline in QTcF at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in QTcF Changes From Baseline Between 250 Milligram (mg) BI 409306 and Placebo Takes Its Maximum 1 hour after drug intake	-0.4 milliseconds Standard Error 0.5	3.3 milliseconds Standard Error 0.7
Change From Baseline in QTcF at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in QTcF Changes From Baseline Between 250 Milligram (mg) BI 409306 and Placebo Takes Its Maximum 1 hour and 30 minutes after drug intake	-0.0 milliseconds Standard Error 0.5	2.7 milliseconds Standard Error 0.7
Change From Baseline in QTcF at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in QTcF Changes From Baseline Between 250 Milligram (mg) BI 409306 and Placebo Takes Its Maximum 2 hours after drug intake	-0.1 milliseconds Standard Error 0.5	1.7 milliseconds Standard Error 0.7
Change From Baseline in QTcF at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in QTcF Changes From Baseline Between 250 Milligram (mg) BI 409306 and Placebo Takes Its Maximum 2 hours and 30 minutes after drug intake	-1.9 milliseconds Standard Error 0.6	-0.7 milliseconds Standard Error 0.8
Change From Baseline in QTcF at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in QTcF Changes From Baseline Between 250 Milligram (mg) BI 409306 and Placebo Takes Its Maximum 3 hours after drug intake	0.4 milliseconds Standard Error 0.5	1.3 milliseconds Standard Error 0.7
Change From Baseline in QTcF at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in QTcF Changes From Baseline Between 250 Milligram (mg) BI 409306 and Placebo Takes Its Maximum 4 hours after drug intake	1.0 milliseconds Standard Error 0.5	1.6 milliseconds Standard Error 0.8
Change From Baseline in QTcF at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in QTcF Changes From Baseline Between 250 Milligram (mg) BI 409306 and Placebo Takes Its Maximum 8 hours after drug intake	-6.8 milliseconds Standard Error 0.7	-7.3 milliseconds Standard Error 0.9
Change From Baseline in QTcF at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in QTcF Changes From Baseline Between 250 Milligram (mg) BI 409306 and Placebo Takes Its Maximum 12 hours after drug intake	-0.9 milliseconds Standard Error 0.7	-0.9 milliseconds Standard Error 1.0
Change From Baseline in QTcF at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in QTcF Changes From Baseline Between 250 Milligram (mg) BI 409306 and Placebo Takes Its Maximum 24 hours after drug intake	-6.3 milliseconds Standard Error 0.6	-5.7 milliseconds Standard Error 0.8

SECONDARY outcome

Timeframe: Baseline, 20 minutes (min), 40 min, 1 hour (h), 1 h 30 min, 2 h, 2 h 30 min, 3 h, 4 h, 8 h, 12 h, 24 h after study drug administration

Population: ECG Set: This participant set included all randomized participants who received at least one dose of any trial medication and who had at least one on-treatment value for at least one electrocardiogram (ECG) endpoint, which was not excluded due to ECG-relevant important protocol deviations (e.g. the use of pro-arrhythmic medications).

QTcF is the QT interval (Electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) corrected using Fridericia's formula. Change from baseline in QTcF at that timepoint between 20 minutes to 24 hours after drug administration where the difference of means in QTcF changes from baseline between moxifloxacin and placebo takes its maximum.

A linear mixed-effects model for repeated measurements based on Schall and Ring (MMRM) was fitted to the observations for moxifloxacin and the 2 placebo periods.

Total number of participants per treatment and timepoint can be lower than 47 due to participants having left their treatment sequence before being exposed to the respective treatment, or due to exclusion of individual participant ECG data at timepoints affected by ECG-relevant important protocol deviations.

Outcome measures

Measure	Placebo to BI 409306 in 2 Periods n=1000 Observations Placebo administered orally as a single dose (5 film-coated tablets) taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. Placebo was administered in two treatment periods.	50 Milligram (mg) BI 409306 n=495 Observations 50 milligram (mg) BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets) taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period.
Change From Baseline in QTcF at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in QTcF Changes From Baseline Between Moxifloxacin and Placebo Takes Its Maximum 4 hours after drug intake	1.0 milliseconds Standard Error 0.6	11.7 milliseconds Standard Error 0.9
Change From Baseline in QTcF at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in QTcF Changes From Baseline Between Moxifloxacin and Placebo Takes Its Maximum 8 hours after drug intake	-7.0 milliseconds Standard Error 0.7	2.3 milliseconds Standard Error 1.0
Change From Baseline in QTcF at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in QTcF Changes From Baseline Between Moxifloxacin and Placebo Takes Its Maximum 20 min after drug intake	-1.5 milliseconds Standard Error 0.4	-1.2 milliseconds Standard Error 0.6
Change From Baseline in QTcF at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in QTcF Changes From Baseline Between Moxifloxacin and Placebo Takes Its Maximum 40 minutes after drug intake	-1.0 milliseconds Standard Error 0.5	7.7 milliseconds Standard Error 0.7
Change From Baseline in QTcF at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in QTcF Changes From Baseline Between Moxifloxacin and Placebo Takes Its Maximum 1 hour after drug intake	-0.5 milliseconds Standard Error 0.5	11.4 milliseconds Standard Error 0.7
Change From Baseline in QTcF at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in QTcF Changes From Baseline Between Moxifloxacin and Placebo Takes Its Maximum 1 h 30 min after drug intake=timepoint of maximum	-0.1 milliseconds Standard Error 0.5	12.0 milliseconds Standard Error 0.8
Change From Baseline in QTcF at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in QTcF Changes From Baseline Between Moxifloxacin and Placebo Takes Its Maximum 2 hours after drug intake	-0.1 milliseconds Standard Error 0.5	11.8 milliseconds Standard Error 0.7
Change From Baseline in QTcF at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in QTcF Changes From Baseline Between Moxifloxacin and Placebo Takes Its Maximum 2 hours and 30 minutes after drug intake	-2.0 milliseconds Standard Error 0.6	8.4 milliseconds Standard Error 0.9
Change From Baseline in QTcF at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in QTcF Changes From Baseline Between Moxifloxacin and Placebo Takes Its Maximum 3 hours after drug intake	0.4 milliseconds Standard Error 0.6	11.4 milliseconds Standard Error 0.9
Change From Baseline in QTcF at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in QTcF Changes From Baseline Between Moxifloxacin and Placebo Takes Its Maximum 12 hours after drug intake	-0.9 milliseconds Standard Error 0.7	5.0 milliseconds Standard Error 1.0
Change From Baseline in QTcF at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in QTcF Changes From Baseline Between Moxifloxacin and Placebo Takes Its Maximum 24 hours after drug intake	-6.5 milliseconds Standard Error 0.6	-0.7 milliseconds Standard Error 0.9

SECONDARY outcome

Timeframe: Baseline, 20 minutes (min), 40 min, 1 hour (h), 1 h 30 min, 2 h, 2 h 30 min, 3 h, 4 h, 8 h, 12 h, 24 h after study drug administration

Population: ECG Set: This participant set included all randomized participants who received at least one dose of any trial medication and who had at least one on-treatment value for at least one electrocardiogram (ECG) endpoint, which was not excluded due to ECG-relevant important protocol deviations (e.g. the use of pro-arrhythmic medications).

QTcF is the QT interval (Electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) corrected using Fridericia's formula. Change from baseline in QTcF at 2 hours after drug administration.

A linear mixed-effects model for repeated measurements based on Schall and Ring (MMRM) was fitted to the observations for moxifloxacin and the 2 placebo periods.

Total number of participants per treatment and timepoint can be lower than 47 due to participants having left their treatment sequence before being exposed to the respective treatment, or due to exclusion of individual participant ECG data at timepoints affected by ECG-relevant important protocol deviations.

Outcome measures

Measure	Placebo to BI 409306 in 2 Periods n=91 Observations Placebo administered orally as a single dose (5 film-coated tablets) taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. Placebo was administered in two treatment periods.	50 Milligram (mg) BI 409306 n=45 Observations 50 milligram (mg) BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets) taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period.
Change From Baseline in QTcF at 2 Hours After Drug Administration (Assessment of Assay Sensitivity)	-0.1 milliseconds Standard Error 0.5	11.8 milliseconds Standard Error 0.7

SECONDARY outcome

Timeframe: Baseline, 20 minutes (min), 40 min, 1 hour (h), 1 h 30 min, 2 h, 2 h 30 min, 3 h, 4 h, 8 h, 12 h, 24 h after study drug administration

Population: ECG Set: This participant set included all randomized participants who received at least one dose of any trial medication and who had at least one on-treatment value for at least one electrocardiogram (ECG) endpoint, which was not excluded due to ECG-relevant important protocol deviations (e.g. the use of pro-arrhythmic medications).

QTcF is the QT interval (Electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) corrected using Fridericia's formula. Change from baseline in QTcF at 3 hours after drug administration.

A linear mixed-effects model for repeated measurements based on Schall and Ring (MMRM) was fitted to the observations for moxifloxacin and the 2 placebo periods.

Total number of participants per treatment and timepoint can be lower than 47 due to participants having left their treatment sequence before being exposed to the respective treatment, or due to exclusion of individual participant ECG data at timepoints affected by ECG-relevant important protocol deviations.

Outcome measures

Measure	Placebo to BI 409306 in 2 Periods n=91 Observations Placebo administered orally as a single dose (5 film-coated tablets) taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. Placebo was administered in two treatment periods.	50 Milligram (mg) BI 409306 n=45 Observations 50 milligram (mg) BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets) taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period.
Change From Baseline in QTcF at 3 Hours After Drug Administration (Assessment of Assay Sensitivity)	0.4 milliseconds Standard Error 0.6	11.4 milliseconds Standard Error 0.9

SECONDARY outcome

Timeframe: Baseline, 20 minutes (min), 40 min, 1 hour (h), 1 h 30 min, 2 h, 2 h 30 min, 3 h, 4 h, 8 h, 12 h, 24 h after study drug administration

Population: ECG Set: This participant set included all randomized participants who received at least one dose of any trial medication and who had at least one on-treatment value for at least one electrocardiogram (ECG) endpoint, which was not excluded due to ECG-relevant important protocol deviations (e.g. the use of pro-arrhythmic medications).

QTcF is the QT interval (Electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) corrected using Fridericia's formula. Change from baseline in QTcF at 4 hours after drug administration.

A linear mixed-effects model for repeated measurements based on Schall and Ring (MMRM) was fitted to the observations for moxifloxacin and the 2 placebo periods.

Total number of participants per treatment and timepoint can be lower than 47 due to participants having left their treatment sequence before being exposed to the respective treatment, or due to exclusion of individual participant ECG data at timepoints affected by ECG-relevant important protocol deviations.

Outcome measures

Measure	Placebo to BI 409306 in 2 Periods n=91 Observations Placebo administered orally as a single dose (5 film-coated tablets) taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. Placebo was administered in two treatment periods.	50 Milligram (mg) BI 409306 n=45 Observations 50 milligram (mg) BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets) taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period.
Change From Baseline in QTcF at 4 Hours After Drug Administration (Assessment of Assay Sensitivity)	1.0 milliseconds Standard Error 0.6	11.7 milliseconds Standard Error 0.9

SECONDARY outcome

Timeframe: Baseline, 20 minutes (min), 40 min, 1 hour (h), 1 h 30 min, 2 h, 2 h 30 min, 3 h, 4 h, 8 h, 12 h, 24 h after study drug administration

Population: ECG Set: This participant set included all randomized participants who received at least one dose of any trial medication and who had at least one on-treatment value for at least one electrocardiogram (ECG) endpoint, which was not excluded due to ECG-relevant important protocol deviations (e.g. the use of pro-arrhythmic medications).

Change from baseline in heart rate (HR) at each timepoint between 20 minutes to 24 hours after drug administration where the difference of means in heart rate changes from baseline between 50 milligram (mg) BI 409306 and placebo takes its maximum.

A linear mixed-effects model for repeated measurements based on Schall and Ring (MMRM) was fitted to the observations for 50 mg BI 409306 and the 2 placebo periods.

Total number of participants per treatment and timepoint can be lower than 47 due to participants having left their treatment sequence before being exposed to the respective treatment, or due to exclusion of individual participant ECG data at timepoints affected by ECG-relevant important protocol deviations.

Outcome measures

Measure	Placebo to BI 409306 in 2 Periods n=1000 Observations Placebo administered orally as a single dose (5 film-coated tablets) taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. Placebo was administered in two treatment periods.	50 Milligram (mg) BI 409306 n=493 Observations 50 milligram (mg) BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets) taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period.
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 50 Milligram (mg) BI 409306 and Placebo Takes Its Maximum 20 min after drug intake = timepoint of maximum	0.6 beats / minute Standard Error 0.4	3.0 beats / minute Standard Error 0.5
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 50 Milligram (mg) BI 409306 and Placebo Takes Its Maximum 40 minutes (min) after drug intake	0.4 beats / minute Standard Error 0.4	2.5 beats / minute Standard Error 0.5
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 50 Milligram (mg) BI 409306 and Placebo Takes Its Maximum 1 hour after drug intake	0.5 beats / minute Standard Error 0.4	1.9 beats / minute Standard Error 0.5
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 50 Milligram (mg) BI 409306 and Placebo Takes Its Maximum 1 hour and 30 minutes after drug intake	0.7 beats / minute Standard Error 0.4	0.8 beats / minute Standard Error 0.5
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 50 Milligram (mg) BI 409306 and Placebo Takes Its Maximum 2 hours after drug intake	0.9 beats / minute Standard Error 0.4	0.8 beats / minute Standard Error 0.5
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 50 Milligram (mg) BI 409306 and Placebo Takes Its Maximum 2 hours and 30 minutes after drug intake	1.7 beats / minute Standard Error 0.4	1.5 beats / minute Standard Error 0.5
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 50 Milligram (mg) BI 409306 and Placebo Takes Its Maximum 3 hours after drug intake	1.4 beats / minute Standard Error 0.4	1.9 beats / minute Standard Error 0.6
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 50 Milligram (mg) BI 409306 and Placebo Takes Its Maximum 4 hours after drug intake	2.5 beats / minute Standard Error 0.4	2.4 beats / minute Standard Error 0.5
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 50 Milligram (mg) BI 409306 and Placebo Takes Its Maximum 8 hours after drug intake	6.0 beats / minute Standard Error 0.5	6.5 beats / minute Standard Error 0.7
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 50 Milligram (mg) BI 409306 and Placebo Takes Its Maximum 12 hours after drug intake	11.6 beats / minute Standard Error 0.5	11.0 beats / minute Standard Error 0.7
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 50 Milligram (mg) BI 409306 and Placebo Takes Its Maximum 24 hours after drug intake	6.9 beats / minute Standard Error 0.5	5.7 beats / minute Standard Error 0.6

SECONDARY outcome

Timeframe: Baseline, 20 minutes (min), 40 min, 1 hour (h), 1 h 30 min, 2 h, 2 h 30 min, 3 h, 4 h, 8 h, 12 h, 24 h after study drug administration

Population: ECG Set: This participant set included all randomized participants who received at least one dose of any trial medication and who had at least one on-treatment value for at least one electrocardiogram (ECG) endpoint, which was not excluded due to ECG-relevant important protocol deviations (e.g. the use of pro-arrhythmic medications).

Change from baseline in heart rate (HR) at that timepoint between 20 minutes to 24 hours after drug administration where the difference of means in heart rate changes from baseline between 250 milligram (mg) BI 409306 and placebo takes its maximum.

A linear mixed-effects model for repeated measurements based on Schall and Ring (MMRM) was fitted to the observations for 250 mg BI 409306 and the 2 placebo periods.

Total number of participants per treatment and timepoint can be lower than 47 due to participants having left their treatment sequence before being exposed to the respective treatment, or due to exclusion of individual participant ECG data at timepoints affected by ECG-relevant important protocol deviations.

Outcome measures

Measure	Placebo to BI 409306 in 2 Periods n=1000 Observations Placebo administered orally as a single dose (5 film-coated tablets) taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. Placebo was administered in two treatment periods.	50 Milligram (mg) BI 409306 n=505 Observations 50 milligram (mg) BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets) taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period.
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 250 Milligram (mg) BI 409306 and Placebo Takes Its Maximum 20 minutes (min) after drug intake	0.6 beats / minute Standard Error 0.6	8.9 beats / minute Standard Error 0.8
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 250 Milligram (mg) BI 409306 and Placebo Takes Its Maximum 40 min after drug intake = timepoint of maximum	0.3 beats / minute Standard Error 0.5	12.0 beats / minute Standard Error 0.6
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 250 Milligram (mg) BI 409306 and Placebo Takes Its Maximum 1 hour after drug intake	0.4 beats / minute Standard Error 0.5	8.1 beats / minute Standard Error 0.6
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 250 Milligram (mg) BI 409306 and Placebo Takes Its Maximum 1 hour and 30 minutes after drug intake	0.6 beats / minute Standard Error 0.5	4.4 beats / minute Standard Error 0.6
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 250 Milligram (mg) BI 409306 and Placebo Takes Its Maximum 2 hours after drug intake	0.8 beats / minute Standard Error 0.5	3.2 beats / minute Standard Error 0.6
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 250 Milligram (mg) BI 409306 and Placebo Takes Its Maximum 2 hours and 30 minutes after drug intake	1.6 beats / minute Standard Error 0.5	2.9 beats / minute Standard Error 0.6
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 250 Milligram (mg) BI 409306 and Placebo Takes Its Maximum 3 hours after drug intake	1.4 beats / minute Standard Error 0.5	1.9 beats / minute Standard Error 0.6
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 250 Milligram (mg) BI 409306 and Placebo Takes Its Maximum 4 hours after drug intake	2.4 beats / minute Standard Error 0.5	3.2 beats / minute Standard Error 0.6
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 250 Milligram (mg) BI 409306 and Placebo Takes Its Maximum 8 hours after drug intake	5.9 beats / minute Standard Error 0.5	6.5 beats / minute Standard Error 0.7
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 250 Milligram (mg) BI 409306 and Placebo Takes Its Maximum 12 hours after drug intake	11.5 beats / minute Standard Error 0.5	11.5 beats / minute Standard Error 0.7
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 250 Milligram (mg) BI 409306 and Placebo Takes Its Maximum 24 hours after drug intake	6.8 beats / minute Standard Error 0.5	6.8 beats / minute Standard Error 0.6

SECONDARY outcome

Timeframe: Baseline, 20 minutes (min), 40 min, 1 hour (h), 1 h 30 min, 2 h, 2 h 30 min, 3 h, 4 h, 8 h, 12 h, 24 h after study drug administration

Population: ECG Set: This participant set included all randomized participants who received at least one dose of any trial medication and who had at least one on-treatment value for at least one electrocardiogram (ECG) endpoint, which was not excluded due to ECG-relevant important protocol deviations (e.g. the use of pro-arrhythmic medications).

Change from baseline in heart rate (HR) at that timepoint between 20 minutes to 24 hours after drug administration where the difference of means in heart rate changes from baseline between 50 milligram (mg) BI 409306 and placebo takes its minimum.

A linear mixed-effects model for repeated measurements based on Schall and Ring (MMRM) was fitted to the observations for 50 mg BI 409306 and the 2 placebo periods.

Total number of participants per treatment and timepoint can be lower than 47 due to participants having left their treatment sequence before being exposed to the respective treatment, or due to exclusion of individual participant ECG data at timepoints affected by ECG-relevant important protocol deviations.

Outcome measures

Measure	Placebo to BI 409306 in 2 Periods n=1000 Observations Placebo administered orally as a single dose (5 film-coated tablets) taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. Placebo was administered in two treatment periods.	50 Milligram (mg) BI 409306 n=493 Observations 50 milligram (mg) BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets) taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period.
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 50 Milligram (mg) BI 409306 and Placebo Takes Its Minimum 20 min after drug intake	0.6 beats / minute Standard Error 0.4	3.0 beats / minute Standard Error 0.5
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 50 Milligram (mg) BI 409306 and Placebo Takes Its Minimum 40 minutes after drug intake	0.4 beats / minute Standard Error 0.4	2.5 beats / minute Standard Error 0.5
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 50 Milligram (mg) BI 409306 and Placebo Takes Its Minimum 1 hour after drug intake	0.5 beats / minute Standard Error 0.4	1.9 beats / minute Standard Error 0.5
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 50 Milligram (mg) BI 409306 and Placebo Takes Its Minimum 1 hour and 30 minutes after drug intake	0.7 beats / minute Standard Error 0.4	0.8 beats / minute Standard Error 0.5
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 50 Milligram (mg) BI 409306 and Placebo Takes Its Minimum 2 hours after drug intake	0.9 beats / minute Standard Error 0.4	0.8 beats / minute Standard Error 0.5
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 50 Milligram (mg) BI 409306 and Placebo Takes Its Minimum 2 hours and 30 minutes after drug intake	1.7 beats / minute Standard Error 0.4	1.5 beats / minute Standard Error 0.5
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 50 Milligram (mg) BI 409306 and Placebo Takes Its Minimum 3 hours after drug intake	1.4 beats / minute Standard Error 0.4	1.9 beats / minute Standard Error 0.6
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 50 Milligram (mg) BI 409306 and Placebo Takes Its Minimum 4 hours after drug intake	2.5 beats / minute Standard Error 0.4	2.4 beats / minute Standard Error 0.5
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 50 Milligram (mg) BI 409306 and Placebo Takes Its Minimum 8 hours after drug intake	6.0 beats / minute Standard Error 0.5	6.5 beats / minute Standard Error 0.7
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 50 Milligram (mg) BI 409306 and Placebo Takes Its Minimum 12 hours after drug intake	11.6 beats / minute Standard Error 0.5	11.0 beats / minute Standard Error 0.7
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 50 Milligram (mg) BI 409306 and Placebo Takes Its Minimum 24 hours after drug intake = timepoint of minimum	6.9 beats / minute Standard Error 0.5	5.7 beats / minute Standard Error 0.6

SECONDARY outcome

Timeframe: Baseline, 20 minutes (min), 40 min, 1 hour (h), 1 h 30 min, 2 h, 2 h 30 min, 3 h, 4 h, 8 h, 12 h, 24 h after study drug administration

Population: ECG Set: This participant set included all randomized participants who received at least one dose of any trial medication and who had at least one on-treatment value for at least one electrocardiogram (ECG) endpoint, which was not excluded due to ECG-relevant important protocol deviations (e.g. the use of pro-arrhythmic medications).

Change from baseline in heart rate (HR) at that timepoint between 20 minutes to 24 hours after drug administration where the difference of means in heart rate changes from baseline between 250 milligram (mg) BI 409306 and placebo takes its minimum.

A linear mixed-effects model for repeated measurements based on Schall and Ring (MMRM) was fitted to the observations for 250 mg BI 409306 and the 2 placebo periods.

Total number of participants per treatment and timepoint can be lower than 47 due to participants having left their treatment sequence before being exposed to the respective treatment, or due to exclusion of individual participant ECG data at timepoints affected by ECG-relevant important protocol deviations.

Outcome measures

Measure	Placebo to BI 409306 in 2 Periods n=1000 Observations Placebo administered orally as a single dose (5 film-coated tablets) taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period. Placebo was administered in two treatment periods.	50 Milligram (mg) BI 409306 n=505 Observations 50 milligram (mg) BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets) taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period.
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 250 Milligram (mg) BI 409306 and Placebo Takes Its Minimum 20 min after drug intake	0.6 beats / minute Standard Error 0.6	8.9 beats / minute Standard Error 0.8
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 250 Milligram (mg) BI 409306 and Placebo Takes Its Minimum 40 minutes after drug intake	0.3 beats / minute Standard Error 0.5	12.0 beats / minute Standard Error 0.6
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 250 Milligram (mg) BI 409306 and Placebo Takes Its Minimum 1 hour after drug intake	0.4 beats / minute Standard Error 0.5	8.1 beats / minute Standard Error 0.6
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 250 Milligram (mg) BI 409306 and Placebo Takes Its Minimum 1 hour and 30 minutes after drug intake	0.6 beats / minute Standard Error 0.5	4.4 beats / minute Standard Error 0.6
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 250 Milligram (mg) BI 409306 and Placebo Takes Its Minimum 2 hours after drug intake	0.8 beats / minute Standard Error 0.5	3.2 beats / minute Standard Error 0.6
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 250 Milligram (mg) BI 409306 and Placebo Takes Its Minimum 2 hours and 30 minutes after drug intake	1.6 beats / minute Standard Error 0.5	2.9 beats / minute Standard Error 0.6
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 250 Milligram (mg) BI 409306 and Placebo Takes Its Minimum 3 hours after drug intake	1.4 beats / minute Standard Error 0.5	1.9 beats / minute Standard Error 0.6
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 250 Milligram (mg) BI 409306 and Placebo Takes Its Minimum 4 hours after drug intake	2.4 beats / minute Standard Error 0.5	3.2 beats / minute Standard Error 0.6
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 250 Milligram (mg) BI 409306 and Placebo Takes Its Minimum 8 hours after drug intake	5.9 beats / minute Standard Error 0.5	6.5 beats / minute Standard Error 0.7
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 250 Milligram (mg) BI 409306 and Placebo Takes Its Minimum 12 hours after drug intake=timepoint of minimum	11.5 beats / minute Standard Error 0.5	11.5 beats / minute Standard Error 0.7
Change From Baseline in Heart Rate (HR) at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in Heart Rate Changes From Baseline Between 250 Milligram (mg) BI 409306 and Placebo Takes Its Minimum 24 hours after drug intake	6.8 beats / minute Standard Error 0.5	6.8 beats / minute Standard Error 0.6

Adverse Events

Placebo 1 to BI 409306

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo 2 to BI 409306

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

50 Milligram (mg) BI 409306

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

250 Milligram (mg) BI 409306

Serious events: 0 serious events

Other events: 36 other events

Deaths: 0 deaths

400 Milligram (mg) Moxifloxacin

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo 1 to BI 409306 n=45 participants at risk Placebo 1 to BI 409306 administered orally as a single dose (5 film-coated tablets) taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period.	Placebo 2 to BI 409306 n=46 participants at risk Placebo 2 to BI 409306 administered orally as a single dose (5 film-coated tablets) taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period.	50 Milligram (mg) BI 409306 n=45 participants at risk 50 milligram (mg) BI 409306 administered orally as a single dose (1 film-coated tablet plus 4 film-coated placebo tablets) taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period.	250 Milligram (mg) BI 409306 n=46 participants at risk 250 mg BI 409306 administered orally as a single dose (5 film-coated tablets) taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period.	400 Milligram (mg) Moxifloxacin n=45 participants at risk 400 mg moxifloxacin administered orally as a single dose (1 film-coated tablet) taken with 240 milliliter of water after an overnight fast of at least 10 hours on day 1 of the treatment period.
Eye disorders Chromatopsia	0.00% 0/45 • On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days. Treated set (TS): This participant set included all randomized participants who received at least one dose of any trial medication. Each treatment represents one period out of five treatment periods in the treatment sequences and only includes the total number of participants exposed to that treatment. Total number of participants per treatment is lower than number of participants in TS due to participants having left the sequence before being exposed to the respective treatment.	2.2% 1/46 • On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days. Treated set (TS): This participant set included all randomized participants who received at least one dose of any trial medication. Each treatment represents one period out of five treatment periods in the treatment sequences and only includes the total number of participants exposed to that treatment. Total number of participants per treatment is lower than number of participants in TS due to participants having left the sequence before being exposed to the respective treatment.	6.7% 3/45 • On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days. Treated set (TS): This participant set included all randomized participants who received at least one dose of any trial medication. Each treatment represents one period out of five treatment periods in the treatment sequences and only includes the total number of participants exposed to that treatment. Total number of participants per treatment is lower than number of participants in TS due to participants having left the sequence before being exposed to the respective treatment.	41.3% 19/46 • On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days. Treated set (TS): This participant set included all randomized participants who received at least one dose of any trial medication. Each treatment represents one period out of five treatment periods in the treatment sequences and only includes the total number of participants exposed to that treatment. Total number of participants per treatment is lower than number of participants in TS due to participants having left the sequence before being exposed to the respective treatment.	0.00% 0/45 • On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days. Treated set (TS): This participant set included all randomized participants who received at least one dose of any trial medication. Each treatment represents one period out of five treatment periods in the treatment sequences and only includes the total number of participants exposed to that treatment. Total number of participants per treatment is lower than number of participants in TS due to participants having left the sequence before being exposed to the respective treatment.
Eye disorders Photophobia	0.00% 0/45 • On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days. Treated set (TS): This participant set included all randomized participants who received at least one dose of any trial medication. Each treatment represents one period out of five treatment periods in the treatment sequences and only includes the total number of participants exposed to that treatment. Total number of participants per treatment is lower than number of participants in TS due to participants having left the sequence before being exposed to the respective treatment.	2.2% 1/46 • On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days. Treated set (TS): This participant set included all randomized participants who received at least one dose of any trial medication. Each treatment represents one period out of five treatment periods in the treatment sequences and only includes the total number of participants exposed to that treatment. Total number of participants per treatment is lower than number of participants in TS due to participants having left the sequence before being exposed to the respective treatment.	8.9% 4/45 • On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days. Treated set (TS): This participant set included all randomized participants who received at least one dose of any trial medication. Each treatment represents one period out of five treatment periods in the treatment sequences and only includes the total number of participants exposed to that treatment. Total number of participants per treatment is lower than number of participants in TS due to participants having left the sequence before being exposed to the respective treatment.	30.4% 14/46 • On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days. Treated set (TS): This participant set included all randomized participants who received at least one dose of any trial medication. Each treatment represents one period out of five treatment periods in the treatment sequences and only includes the total number of participants exposed to that treatment. Total number of participants per treatment is lower than number of participants in TS due to participants having left the sequence before being exposed to the respective treatment.	0.00% 0/45 • On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days. Treated set (TS): This participant set included all randomized participants who received at least one dose of any trial medication. Each treatment represents one period out of five treatment periods in the treatment sequences and only includes the total number of participants exposed to that treatment. Total number of participants per treatment is lower than number of participants in TS due to participants having left the sequence before being exposed to the respective treatment.
Eye disorders Photopsia	0.00% 0/45 • On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days. Treated set (TS): This participant set included all randomized participants who received at least one dose of any trial medication. Each treatment represents one period out of five treatment periods in the treatment sequences and only includes the total number of participants exposed to that treatment. Total number of participants per treatment is lower than number of participants in TS due to participants having left the sequence before being exposed to the respective treatment.	0.00% 0/46 • On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days. Treated set (TS): This participant set included all randomized participants who received at least one dose of any trial medication. Each treatment represents one period out of five treatment periods in the treatment sequences and only includes the total number of participants exposed to that treatment. Total number of participants per treatment is lower than number of participants in TS due to participants having left the sequence before being exposed to the respective treatment.	0.00% 0/45 • On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days. Treated set (TS): This participant set included all randomized participants who received at least one dose of any trial medication. Each treatment represents one period out of five treatment periods in the treatment sequences and only includes the total number of participants exposed to that treatment. Total number of participants per treatment is lower than number of participants in TS due to participants having left the sequence before being exposed to the respective treatment.	15.2% 7/46 • On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days. Treated set (TS): This participant set included all randomized participants who received at least one dose of any trial medication. Each treatment represents one period out of five treatment periods in the treatment sequences and only includes the total number of participants exposed to that treatment. Total number of participants per treatment is lower than number of participants in TS due to participants having left the sequence before being exposed to the respective treatment.	0.00% 0/45 • On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days. Treated set (TS): This participant set included all randomized participants who received at least one dose of any trial medication. Each treatment represents one period out of five treatment periods in the treatment sequences and only includes the total number of participants exposed to that treatment. Total number of participants per treatment is lower than number of participants in TS due to participants having left the sequence before being exposed to the respective treatment.
Eye disorders Visual brightness	0.00% 0/45 • On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days. Treated set (TS): This participant set included all randomized participants who received at least one dose of any trial medication. Each treatment represents one period out of five treatment periods in the treatment sequences and only includes the total number of participants exposed to that treatment. Total number of participants per treatment is lower than number of participants in TS due to participants having left the sequence before being exposed to the respective treatment.	0.00% 0/46 • On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days. Treated set (TS): This participant set included all randomized participants who received at least one dose of any trial medication. Each treatment represents one period out of five treatment periods in the treatment sequences and only includes the total number of participants exposed to that treatment. Total number of participants per treatment is lower than number of participants in TS due to participants having left the sequence before being exposed to the respective treatment.	2.2% 1/45 • On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days. Treated set (TS): This participant set included all randomized participants who received at least one dose of any trial medication. Each treatment represents one period out of five treatment periods in the treatment sequences and only includes the total number of participants exposed to that treatment. Total number of participants per treatment is lower than number of participants in TS due to participants having left the sequence before being exposed to the respective treatment.	6.5% 3/46 • On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days. Treated set (TS): This participant set included all randomized participants who received at least one dose of any trial medication. Each treatment represents one period out of five treatment periods in the treatment sequences and only includes the total number of participants exposed to that treatment. Total number of participants per treatment is lower than number of participants in TS due to participants having left the sequence before being exposed to the respective treatment.	0.00% 0/45 • On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days. Treated set (TS): This participant set included all randomized participants who received at least one dose of any trial medication. Each treatment represents one period out of five treatment periods in the treatment sequences and only includes the total number of participants exposed to that treatment. Total number of participants per treatment is lower than number of participants in TS due to participants having left the sequence before being exposed to the respective treatment.
Eye disorders Visual impairment	0.00% 0/45 • On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days. Treated set (TS): This participant set included all randomized participants who received at least one dose of any trial medication. Each treatment represents one period out of five treatment periods in the treatment sequences and only includes the total number of participants exposed to that treatment. Total number of participants per treatment is lower than number of participants in TS due to participants having left the sequence before being exposed to the respective treatment.	0.00% 0/46 • On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days. Treated set (TS): This participant set included all randomized participants who received at least one dose of any trial medication. Each treatment represents one period out of five treatment periods in the treatment sequences and only includes the total number of participants exposed to that treatment. Total number of participants per treatment is lower than number of participants in TS due to participants having left the sequence before being exposed to the respective treatment.	0.00% 0/45 • On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days. Treated set (TS): This participant set included all randomized participants who received at least one dose of any trial medication. Each treatment represents one period out of five treatment periods in the treatment sequences and only includes the total number of participants exposed to that treatment. Total number of participants per treatment is lower than number of participants in TS due to participants having left the sequence before being exposed to the respective treatment.	6.5% 3/46 • On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days. Treated set (TS): This participant set included all randomized participants who received at least one dose of any trial medication. Each treatment represents one period out of five treatment periods in the treatment sequences and only includes the total number of participants exposed to that treatment. Total number of participants per treatment is lower than number of participants in TS due to participants having left the sequence before being exposed to the respective treatment.	0.00% 0/45 • On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days. Treated set (TS): This participant set included all randomized participants who received at least one dose of any trial medication. Each treatment represents one period out of five treatment periods in the treatment sequences and only includes the total number of participants exposed to that treatment. Total number of participants per treatment is lower than number of participants in TS due to participants having left the sequence before being exposed to the respective treatment.
Gastrointestinal disorders Nausea	0.00% 0/45 • On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days. Treated set (TS): This participant set included all randomized participants who received at least one dose of any trial medication. Each treatment represents one period out of five treatment periods in the treatment sequences and only includes the total number of participants exposed to that treatment. Total number of participants per treatment is lower than number of participants in TS due to participants having left the sequence before being exposed to the respective treatment.	0.00% 0/46 • On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days. Treated set (TS): This participant set included all randomized participants who received at least one dose of any trial medication. Each treatment represents one period out of five treatment periods in the treatment sequences and only includes the total number of participants exposed to that treatment. Total number of participants per treatment is lower than number of participants in TS due to participants having left the sequence before being exposed to the respective treatment.	0.00% 0/45 • On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days. Treated set (TS): This participant set included all randomized participants who received at least one dose of any trial medication. Each treatment represents one period out of five treatment periods in the treatment sequences and only includes the total number of participants exposed to that treatment. Total number of participants per treatment is lower than number of participants in TS due to participants having left the sequence before being exposed to the respective treatment.	17.4% 8/46 • On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days. Treated set (TS): This participant set included all randomized participants who received at least one dose of any trial medication. Each treatment represents one period out of five treatment periods in the treatment sequences and only includes the total number of participants exposed to that treatment. Total number of participants per treatment is lower than number of participants in TS due to participants having left the sequence before being exposed to the respective treatment.	4.4% 2/45 • On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days. Treated set (TS): This participant set included all randomized participants who received at least one dose of any trial medication. Each treatment represents one period out of five treatment periods in the treatment sequences and only includes the total number of participants exposed to that treatment. Total number of participants per treatment is lower than number of participants in TS due to participants having left the sequence before being exposed to the respective treatment.
Cardiac disorders Sinus tachycardia	0.00% 0/45 • On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days. Treated set (TS): This participant set included all randomized participants who received at least one dose of any trial medication. Each treatment represents one period out of five treatment periods in the treatment sequences and only includes the total number of participants exposed to that treatment. Total number of participants per treatment is lower than number of participants in TS due to participants having left the sequence before being exposed to the respective treatment.	0.00% 0/46 • On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days. Treated set (TS): This participant set included all randomized participants who received at least one dose of any trial medication. Each treatment represents one period out of five treatment periods in the treatment sequences and only includes the total number of participants exposed to that treatment. Total number of participants per treatment is lower than number of participants in TS due to participants having left the sequence before being exposed to the respective treatment.	0.00% 0/45 • On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days. Treated set (TS): This participant set included all randomized participants who received at least one dose of any trial medication. Each treatment represents one period out of five treatment periods in the treatment sequences and only includes the total number of participants exposed to that treatment. Total number of participants per treatment is lower than number of participants in TS due to participants having left the sequence before being exposed to the respective treatment.	10.9% 5/46 • On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days. Treated set (TS): This participant set included all randomized participants who received at least one dose of any trial medication. Each treatment represents one period out of five treatment periods in the treatment sequences and only includes the total number of participants exposed to that treatment. Total number of participants per treatment is lower than number of participants in TS due to participants having left the sequence before being exposed to the respective treatment.	0.00% 0/45 • On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days. Treated set (TS): This participant set included all randomized participants who received at least one dose of any trial medication. Each treatment represents one period out of five treatment periods in the treatment sequences and only includes the total number of participants exposed to that treatment. Total number of participants per treatment is lower than number of participants in TS due to participants having left the sequence before being exposed to the respective treatment.
Cardiac disorders Ventricular extrasystoles	2.2% 1/45 • On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days. Treated set (TS): This participant set included all randomized participants who received at least one dose of any trial medication. Each treatment represents one period out of five treatment periods in the treatment sequences and only includes the total number of participants exposed to that treatment. Total number of participants per treatment is lower than number of participants in TS due to participants having left the sequence before being exposed to the respective treatment.	0.00% 0/46 • On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days. Treated set (TS): This participant set included all randomized participants who received at least one dose of any trial medication. Each treatment represents one period out of five treatment periods in the treatment sequences and only includes the total number of participants exposed to that treatment. Total number of participants per treatment is lower than number of participants in TS due to participants having left the sequence before being exposed to the respective treatment.	6.7% 3/45 • On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days. Treated set (TS): This participant set included all randomized participants who received at least one dose of any trial medication. Each treatment represents one period out of five treatment periods in the treatment sequences and only includes the total number of participants exposed to that treatment. Total number of participants per treatment is lower than number of participants in TS due to participants having left the sequence before being exposed to the respective treatment.	4.3% 2/46 • On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days. Treated set (TS): This participant set included all randomized participants who received at least one dose of any trial medication. Each treatment represents one period out of five treatment periods in the treatment sequences and only includes the total number of participants exposed to that treatment. Total number of participants per treatment is lower than number of participants in TS due to participants having left the sequence before being exposed to the respective treatment.	0.00% 0/45 • On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days. Treated set (TS): This participant set included all randomized participants who received at least one dose of any trial medication. Each treatment represents one period out of five treatment periods in the treatment sequences and only includes the total number of participants exposed to that treatment. Total number of participants per treatment is lower than number of participants in TS due to participants having left the sequence before being exposed to the respective treatment.
Nervous system disorders Headache	2.2% 1/45 • On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days. Treated set (TS): This participant set included all randomized participants who received at least one dose of any trial medication. Each treatment represents one period out of five treatment periods in the treatment sequences and only includes the total number of participants exposed to that treatment. Total number of participants per treatment is lower than number of participants in TS due to participants having left the sequence before being exposed to the respective treatment.	2.2% 1/46 • On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days. Treated set (TS): This participant set included all randomized participants who received at least one dose of any trial medication. Each treatment represents one period out of five treatment periods in the treatment sequences and only includes the total number of participants exposed to that treatment. Total number of participants per treatment is lower than number of participants in TS due to participants having left the sequence before being exposed to the respective treatment.	6.7% 3/45 • On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days. Treated set (TS): This participant set included all randomized participants who received at least one dose of any trial medication. Each treatment represents one period out of five treatment periods in the treatment sequences and only includes the total number of participants exposed to that treatment. Total number of participants per treatment is lower than number of participants in TS due to participants having left the sequence before being exposed to the respective treatment.	15.2% 7/46 • On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days. Treated set (TS): This participant set included all randomized participants who received at least one dose of any trial medication. Each treatment represents one period out of five treatment periods in the treatment sequences and only includes the total number of participants exposed to that treatment. Total number of participants per treatment is lower than number of participants in TS due to participants having left the sequence before being exposed to the respective treatment.	2.2% 1/45 • On-treatment period, that is, from administration of study drug until the end of the respective Residual Effect Period (24 hours for BI 409306 and placebo, 4 days for moxifloxacin), up to 4 days. Treated set (TS): This participant set included all randomized participants who received at least one dose of any trial medication. Each treatment represents one period out of five treatment periods in the treatment sequences and only includes the total number of participants exposed to that treatment. Total number of participants per treatment is lower than number of participants in TS due to participants having left the sequence before being exposed to the respective treatment.

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: clintriage.rdg@boehringer-ingelheim.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place