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

Healthy Clinical Trial

Official title:

A Randomised, Single-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, and Pharmacokinetics of Single Rising Doses of BI 1584862 Administered as Tablet to Healthy Male Subjects (SRD Part), and a Randomised, Open-label, Single-dose, Two-way Crossover Part Investigating Relative Bioavailability of BI 1584862 as Tablet With and Without Food in Healthy Male Subjects (FE Part)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05520827
• Other study ID #: 1484-0001
• Secondary ID: 2022-001019-15
• Status: Completed
• Phase: Phase 1
• Start date: September 29, 2022
• Est. completion date: March 6, 2023

Study information

• Verified date: March 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: March 6, 2023
• Est. primary completion date: March 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• History of relevant orthostatic hypotension, fainting spells, or blackouts. Further exclusion criteria apply.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• BI 1584862
BI 1584862
• Placebo
Placebo

Locations

Country	Name	City	State
Germany	Humanpharmakologisches Zentrum Biberach	Biberach

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SRD-part:Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator		Up to 14 days
Primary	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
Primary	FE-part: Maximum measured concentration of BI 1584862 in plasma (Cmax)		Up to 6 days
Secondary	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
Secondary	SRD-Part: Maximum measured concentration of BI 1584862 in plasma (Cmax)		Up to 6 days
Secondary	FE-Part: Area under the concentration-time curve of BI 1584862 in plasma over the time interval from 0 extrapolated to infinity (AUC0-8)		Up to 6 days

External Links

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