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

NCT05945888 | Completed Phase 1

• 2 other identifiers: 1509-00012022-502424-43-00
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• FE part: Maximum measured concentration of the analyte in plasma (Cmax)

  up to 3 days

Secondary Outcomes (3)

• SRD part: AUC 0-24

  up to 3 days

• SRD part: Cmax

  up to 3 days

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

  up to 3 days

Study Arms (4)

SRD part: Treatment group

EXPERIMENTAL

Drug: BI 3000202

SRD part: Placebo group

PLACEBO COMPARATOR

Drug: Placebo matching BI 3000202

FE part: Treatment sequence reference (R) - test (T)

EXPERIMENTAL

Drug: BI 3000202

FE part: Treatment sequence test (T) - reference (R)

EXPERIMENTAL

Drug: BI 3000202

Interventions

BI 3000202 DRUG

BI 3000202

FE part: Treatment sequence reference (R) - test (T); FE part: Treatment sequence test (T) - reference (R); SRD part: Treatment group

Placebo matching BI 3000202 DRUG

Placebo matching BI 3000202

SRD part: Placebo group

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 without any clinically significant abnormalities
• Age of 18 to 45 years (inclusive)
• Body mass index (BMI) of 18.5 to 29.9 kg/m\^2 (inclusive)
• Signed and dated written informed consent in accordance with 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 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)
• 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

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: SRD part: single blinded FE part: open-label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The SRD part of the trial is designed as blinded to subjects, randomised, and placebo-controlled within parallel dose groups. In the FE part, subjects participate in a randomised, open-label, two-way crossover trial part with two treatment periods.

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: July 14, 2023
• Study Start: July 25, 2023
• Primary Completion: November 13, 2023
• Study Completion: November 13, 2023
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)