A Study in Healthy Men to Test How Different Doses of BI 1815368 Are Tolerated and How BI 1815368 is Taken up in the Body With or Without Food

NCT05337592 | Completed Phase 1

• 2 other identifiers: 1485-00012021-006856-16
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Single-rising dose (SRD) part The main objectives of the SRD part of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1815368 in healthy male subjects following oral administration of single rising doses. Bioavailability (BA) part The main objective of the BA part is to investigate the relative bioavailability of a tablet formulation versus oral solution and to assess the influence of food on the relative bioavailability of the tablet formulation.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• SRD part: Occurrence of any treatment-emergent adverse event

  Up to Day 14

• BA part: Area under the concentration-time curve of BI 1815368 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)

  Up to Day 5

• BA part: Maximum measured concentration of BI 1815368 in plasma (Cmax)

  Up to Day 5

Secondary Outcomes (3)

• SRD part: Area under the concentration-time curve of BI 1815368 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)

  up to Day 6

• SRD part: Maximum measured concentration of BI 1815368 in plasma (Cmax)

  up to Day 6

• BA part: Area under the concentration-time curve of BI 1815368 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)

  Up to Day 5

Study Arms (5)

SRD part: BI 1815368

EXPERIMENTAL

Drug: BI 1815368 formulation 1

SRD part: Placebo

PLACEBO COMPARATOR

Drug: Placebo

BA part: T1-R-T2

EXPERIMENTAL

R: BI 1815368 formulation 1, fasted condition T1: BI 1815368 formulation 2, fasted condition T2: BI 1815368 formulation 2, fed condition

Drug: BI 1815368 formulation 1; Drug: BI 1815368 formulation 2

BA part: R-T2-T1

EXPERIMENTAL

Drug: BI 1815368 formulation 1; Drug: BI 1815368 formulation 2

BA part: T2-T1-R

EXPERIMENTAL

Drug: BI 1815368 formulation 1; Drug: BI 1815368 formulation 2

Interventions

BI 1815368 formulation 1 DRUG

BI 1815368 formulation 1

BA part: R-T2-T1; BA part: T1-R-T2; BA part: T2-T1-R; SRD part: BI 1815368

Placebo DRUG

Placebo

SRD part: Placebo

BI 1815368 formulation 2 DRUG

BI 1815368 formulation 2

BA part: R-T2-T1; BA part: T1-R-T2; BA part: T2-T1-R

Eligibility Criteria

• Age: 18 Years - 45 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, as 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 45 years (inclusive)
• Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
• Signed and dated written informed consent in accordance with International Council for Harmonisation- Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

You may not qualify if:

• Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
• Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm)
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
• Any evidence of a concomitant disease assessed as clinically relevant by the investigator
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
• Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
• History of relevant orthostatic hypotension, fainting spells, or blackouts

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Humanpharmakologisches Zentrum Biberach

Biberach, 88397, Germany

Location

Related Links

• Related Info

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: For the Single Rising Dose (SRD) part the participant is blinded. For the bioavailability (BA) part no masking is applicable.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study has 2 parts: a single rising dose (SRD) part and a bioavailability (BA) part. For the SRD part the intervention study model is sequential, while for the BA part the intervention study model is crossover.

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: April 20, 2022
• Study Start: June 14, 2022
• Primary Completion: October 18, 2022
• Study Completion: October 18, 2022
• Last Updated: October 20, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)