A Study in Healthy Men to Test How Different Doses of BI 3000202 Are Tolerated and How Food Influences the Amount of BI 3000202 in the Blood

Healthy Clinical Trial

Official title:

A Randomised, Single-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, and Pharmacokinetics of Single Rising Doses of BI 3000202 Administered as Tablet to Healthy Male Subjects, and a Randomised, Open-label, Single-dose, Two-way Cross-over Relative Bioavailability Comparison of BI 3000202 as Tablet With and Without Food in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05945888
• Other study ID #: 1509-0001
• Secondary ID: 2022-502424-43-0
• Status: Completed
• Phase: Phase 1
• Start date: July 25, 2023
• Est. completion date: November 13, 2023

Study information

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

Clinical Trial Summary

The single rising dose (SRD) part of the trial investigates safety, tolerability, and pharmacokinetics of BI 3000202.

The food effect (FE) part is conducted to assess the effect of food on the relative bioavailability of the BI 3000202 formulation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: November 13, 2023
• Est. primary completion date: November 13, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion criteria

1. 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 without any clinically significant abnormalities

2. Age of 18 to 45 years (inclusive)

3. Body mass index (BMI) of 18.5 to 29.9 kg/m^2 (inclusive)

4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial

Exclusion criteria

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator

2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimeter 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)

3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance

4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator

5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)

7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• BI 3000202
BI 3000202
• Placebo matching BI 3000202
Placebo matching BI 3000202

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.	This is expressed as the percentage of subjects treated with investigational drug who experience such an event.	up to 14 days
Primary	FE part: Area under the concentration-time curve of the analyte in plasma over the dosing interval 0 to 24 hours (AUC 0-24)		up to 3 days
Primary	FE part: Maximum measured concentration of the analyte in plasma (Cmax)		up to 3 days
Secondary	SRD part: AUC 0-24		up to 3 days
Secondary	SRD part: Cmax		up to 3 days
Secondary	FE part: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-8)		up to 3 days

External Links

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