Relative Bioavailability of BI 1015550 Following Oral Administration Under Fed and Fasted Conditions in Healthy Male Subjects

NCT03302078 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 1305-00202017-002271-26
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this trial is to investigate the effect of food on the pharmacokinetics of the oral tablet formulation of BI 1015550 by investigating the relative bioavailability of TF1 under fed and fasted conditions. The assessment of safety and tolerability will be an additional objective of this part.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area Under the Concentration-time Curve of BI 1015550 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

  AUC0-tz, area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 to the last quantifiable data point. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequence', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. Adjusted mean estimates and their difference on log-scale were back-transformed to the original scale.

  Pharmacokinetic samples were collected at 3:00 (hours:minutes) before and 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00 and 120:00 (hours:minutes) after drug administration on day 1.

• Maximum Measured Concentration of BI 1015550 in Plasma (Cmax)

  Cmax, maximum measured concentration of BI 1015550 in plasma. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequence', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. Adjusted mean estimates and their difference on log-scale were back-transformed to the original scale.

  Pharmacokinetic samples were collected at 3:00 (hours:minutes) before and 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00 and 120:00 (hours:minutes) after drug administration on day 1.

Secondary Outcomes (1)

• Area Under the Concentration-time Curve of BI 1015550 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)

  Pharmacokinetic samples were collected at 3:00 (hours:minutes) before and 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00 and 120:00 (hours:minutes) after drug administration on day 1.

Study Arms (2)

BI 1015550 24 milligrams (mg) fed / BI 1015550 24 mg fast

EXPERIMENTAL

Subjects were treated orally in period 1 with single dose of BI 1015550 4x6 mg (24 mg) tablets under fed condition, followed in period 2 with 4x6 mg (24 mg) of BI 1015550 tablets under fasted condition, each treatment with 240 milliliter (mL) water, separated by a wash-out period of at least 7 days between drug administrations.

Drug: BI 1015550

BI 1015550 24 mg fast / BI 1015550 24 mg fed

EXPERIMENTAL

Subjects were treated orally in period 1 with single dose of BI 1015550 4x6 mg (24 mg) tablets under fasted condition, followed in period 2 with 4x6 mg (24 mg) of BI 1015550 tablets under fed condition, each treatment with 240 mL water, separated by a wash-out period of at least 7 days between drug administrations.

Drug: BI 1015550

Interventions

BI 1015550 DRUG

Single dose of BI 1015550 4x6 mg (24 mg) tablets under fed or fasted condition

Also known as: Nerandomilast, JASCAYD®

BI 1015550 24 mg fast / BI 1015550 24 mg fed; BI 1015550 24 milligrams (mg) fed / BI 1015550 24 mg fast

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects according to the assessment of the investigator, based on a complete medical history including a physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
• Age of 18 to 55 years (incl.)
• BMI of 18.5 to 29.9 kg/m2 (incl.)
• Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

You may not qualify if:

• Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR) or Electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant by the investigator
• Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
• Any evidence of a concomitant disease judged as clinically relevant by the investigator
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders
• Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy)
• Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders including but not limited to mood disorders and any signs of suicidality (ideation as well as behavior) in the past
• History of relevant orthostatic hypotension, fainting spells, or blackouts
• Chronic or relevant acute infections
• History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
• Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation)
• Participation in another trial where an investigational drug has been administered within 60 days prior to planned administration of trial medication, or current participation in another trial involving administration of investigational drug
• Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (consumption of more than 30 g per day)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Humanpharmakologisches Zentrum Biberach

Biberach, 88397, Germany

Location

Related Links

• Related Info

MeSH Terms

Interventions

BI 1015550

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2017
• First Posted: October 4, 2017
• Study Start: October 16, 2017
• Primary Completion: December 13, 2017
• Study Completion: December 13, 2017
• Last Updated: November 28, 2025
• Results First Posted: November 28, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)