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 Results

• 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: Number of Any Treatment-emergent Adverse Event Assessed as Drug-related by the Investigator

  Number of any treatment-emergent adverse event assessed as drug-related by the investigator. Percentages were calculated using the total number of participants per treatment as denominator. MedDRA version 26.1 was used for reporting. All adverse events occurring up to 48 hours (2 days) after drug administration were assigned to treatment. Medical judgment was used to determine whether there was a reasonable possibility of a causal relationship between the AE and the given trial treatment, considering all relevant factors, including pattern of reaction, temporal relationship, de-challenge or re-challenge, confounding factors such as concomitant medication, concomitant diseases and relevant history.

  From drug administration on Day 1 plus REP of 48 hours, up to 2 days.

• FE Part: Area Under the Concentration-time Curve of BI 3000202 in Plasma Over the Dosing Interval 0 to 24 Hours (AUC0-24)

  Area under the concentration-time curve of BI 3000202 in plasma over the dosing interval 0 to 24 hours (AUC0-24). The AUC0-24 endpoint was log-transformed (natural logarithm) prior to fitting the Analysis of Variance (ANOVA) model. The ANOVA model accounted for the random effect 'participants within sequences' and fixed effects 'sequence' 'period' and 'treatment'.

  Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administration

• FE Part: Maximum Measured Concentration of BI 3000202 in Plasma (Cmax)

  Maximum measured concentration of BI 3000202 in plasma (Cmax). The Cmax endpoint was log-transformed (natural logarithm) prior to fitting the Analysis of Variance (ANOVA) model. The ANOVA model accounted for the random effect 'participants within sequences' and the fixed effects 'sequence' 'period' and 'treatment'.

  Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administration

Secondary Outcomes (3)

• SRD Part: Area Under the Concentration-time Curve of BI 3000202 in Plasma Over the Dosing Interval 0 to 24 Hours (AUC0-24)

  Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administration

• SRD Part: Maximum Measured Concentration of BI 3000202 in Plasma (Cmax)

  Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administration

• FE Part: Area Under the Concentration-time Curve of BI 3000202 in Plasma Over the Dosing Interval 0 to Infinity (AUC0-∞)

  Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administration

Study Arms (10)

Single rising dose (SRD): Placebo matching BI 3000202

PLACEBO COMPARATOR

SRD part: A single administration of 1 film-coated tablet identical to the active BI 3000202 treatment was orally given with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h).

Drug: BI 3000202

SRD: Dose 1 - BI 3000202

EXPERIMENTAL

SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 1) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.

Drug: BI 3000202; Drug: Placebo matching BI 3000202

SRD: Dose 2 - BI 3000202

EXPERIMENTAL

SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 2) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.

Drug: BI 3000202

SRD: Dose 3 - BI 3000202

EXPERIMENTAL

SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 3) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.

Drug: BI 3000202

SRD: Dose 4 - BI 3000202

EXPERIMENTAL

SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 4) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.

Drug: BI 3000202

SRD: Dose 5 - BI 3000202

EXPERIMENTAL

SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 5) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.

Drug: BI 3000202

SRD: Dose 6 - BI 3000202

EXPERIMENTAL

SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 6) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.

Drug: BI 3000202

SRD: Dose 7 - BI 3000202

EXPERIMENTAL

SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 7) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.

Drug: BI 3000202

Food effect (FE): Low dose III BI 3000202 fasted (R) / fed (T)

EXPERIMENTAL

FE part: In treatment Period 1, participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water after an overnight fast of at least 10 hours (= reference R). In treatment Period 2, participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water 30 minutes after consuming a high-fat, high-calorie breakfast consumed after an overnight fast of at least 10 hours (=test T). There was a minimum 3-day washout period between the two treatments.

Drug: BI 3000202

FE: Low dose III BI 3000202 fed (T) / fasted (R)

EXPERIMENTAL

FE part: In treatment Period 1, participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water 30 minutes after consuming a high-fat, high-calorie breakfast consumed after an overnight fast of at least 10 hours (=test T). In treatment Period 2, participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water 30 minutes after an overnight fast of at least 10 hours (= reference R). There was a minimum 3-day washout period between the two treatments.

Drug: BI 3000202

Interventions

BI 3000202 DRUG

BI 3000202

FE: Low dose III BI 3000202 fed (T) / fasted (R); Food effect (FE): Low dose III BI 3000202 fasted (R) / fed (T); SRD: Dose 1 - BI 3000202; SRD: Dose 2 - BI 3000202; SRD: Dose 3 - BI 3000202; SRD: Dose 4 - BI 3000202; SRD: Dose 5 - BI 3000202; SRD: Dose 6 - BI 3000202; SRD: Dose 7 - BI 3000202; Single rising dose (SRD): Placebo matching BI 3000202

Placebo matching BI 3000202 DRUG

Placebo matching BI 3000202

SRD: Dose 1 - BI 3000202

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

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: Yes

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: June 8, 2026
• Results First Posted: June 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)