A Study in Healthy Men to Test How Different Doses of BI 1584862 Are Tolerated and How BI 1584862 is Taken up in the Body With or Without Food

NCT05520827 | Completed Phase 1

• 2 other identifiers: 1484-00012022-001019-15
• Study Type: interventional
• Target: 77
• 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 1584862 in healthy male subjects following oral administration of single rising doses. Food Effect (FE) part: The main objective of the FE part is to assess the influence of food on the relative bioavailability of the BI 1584862 tablet.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• SRD-part:Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator

  Up to 14 days

• FE-part: Area under the concentration-time curve of BI 1584862 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)

  Up to 6 days

• FE-part: Maximum measured concentration of BI 1584862 in plasma (Cmax)

  Up to 6 days

Secondary Outcomes (3)

• SRD-Part: Area under the concentration-time curve of BI 1584862 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)

  Up to 6 days

• SRD-Part: Maximum measured concentration of BI 1584862 in plasma (Cmax)

  Up to 6 days

• FE-Part: Area under the concentration-time curve of BI 1584862 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)

  Up to 6 days

Study Arms (4)

Single Rising Dose part: BI 1584862

EXPERIMENTAL

Drug: BI 1584862

Single Rising Dose part: Placebo

PLACEBO COMPARATOR

Drug: Placebo

Food effect part: BI 1584862 fed (treatment test, T)/ BI 1584862 fasted (treatment reference, R)

EXPERIMENTAL

Drug: BI 1584862

Food effect part: BI 1584862 fasted (treatment reference, R)/ BI 1584862 fed (treatment test, T)

EXPERIMENTAL

Drug: BI 1584862

Interventions

BI 1584862 DRUG

BI 1584862

Food effect part: BI 1584862 fasted (treatment reference, R)/ BI 1584862 fed (treatment test, T); Food effect part: BI 1584862 fed (treatment test, T)/ BI 1584862 fasted (treatment reference, R); Single Rising Dose part: BI 1584862

Placebo DRUG

Placebo

Single Rising Dose part: Placebo

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(s) 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, in particular liver enzymes (AST/ALT) above upper limit of normal and creatinine exceeding 1.2 mg/dl as confirmed by repeat measurements.
• 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.

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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SRD-Part: parallel-group design FE-Part: two-way crossover design

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: August 30, 2022
• Study Start: September 29, 2022
• Primary Completion: March 6, 2023
• Study Completion: March 6, 2023
• Last Updated: March 9, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)