A Study in Healthy Men to Test Whether Food Affects the Amount of BI 894416 in the Blood

NCT03871595 | Completed Phase 1 Results

• 2 other identifiers: 1371-00212018-004313-41
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Investigate the relative bioavailability of BI 894416 as tablet formulation following a high-fat, high calorie breakfast (Test, T) compared with administration in the fasting state (Reference, R)

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area Under the Concentration-time Curve of BI 894416 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

  Area under the concentration-time curve of BI 894416 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Time points of pharmacokinetic (PK) blood samples are given as planned time relative to start of drug administration.

  Within 3 hours before and then 15 minutes (min), 30 min, 45 min, and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 34 and 48 hours after drug administration.

• Maximum Measured Concentration of BI 894416 in Plasma (Cmax)

  Maximum measured concentration of BI 894416 in plasma (Cmax). Time points of pharmacokinetic (PK) blood samples are given as planned time relative to start of drug administration.

  Within 3 hours before and then 15 minutes (min), 30 min, 45 min, and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 34 and 48 hours after drug administration.

Secondary Outcomes (1)

• Area Under the Concentration-time Curve of BI 894416 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞ )

  Within 3 hours before and then 15 minutes (min), 30 min, 45 min, and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 34 and 48 hours after drug administration.

Study Arms (2)

BI 894416 30 mg fed (T)

EXPERIMENTAL

3 tablets with 10 milligram (mg) of BI 894416 (total: 30 mg) were administered as one single oral dose with 240 milliliter (mL) of water after a high-fat, high-calorie meal (fed conditions) as test treatment (T).

Drug: BI 894416

BI 894416 30 mg fast (R)

EXPERIMENTAL

3 tablets with 10 milligram (mg) of BI 894416 (total: 30 mg) were administered as one single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (fasted conditions) as reference treatment (R).

Drug: BI 894416

Interventions

BI 894416 DRUG

3 tablets with 10 milligram (mg) of BI 894416 (total: 30 mg) were administered as one single oral dose with 240 milliliter (mL) of water.

BI 894416 30 mg fast (R); BI 894416 30 mg fed (T)

Eligibility Criteria

• Age: 18 Years - 50 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 50 years (inclusive)
• BMI of 18.5 to 29.9 kg/m2 (inclusive)
• Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation

You may not qualify if:

• Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR) or Electrocardiogram (ECG) and including the neurological examination) deviating from normal and assessed as clinically relevant by the investigator
• Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 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
• History of relevant orthostatic hypotension, fainting spells, or blackouts
• Chronic or relevant acute infections
• History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
• Use of drugs within 30 days of planned administration of trial medication that might reasonably influence the results of the trial (including drugs that cause QT/QTc interval prolongation)
• Intake of an investigational drug in another clinical trial within 60 days of planned administration of investigational drug in the current trial, or concurrent participation in another clinical trial in which investigational drug is administered
• Smoker (unless the subject quit smoking for at least 3 months prior to first planned administration of trial medication)
• Alcohol abuse (consumption of more than 24 g per day)
• Drug abuse or positive drug screening

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: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 12, 2019
• Study Start: March 20, 2019
• Primary Completion: April 24, 2019
• Study Completion: April 24, 2019
• Last Updated: August 14, 2023
• Results First Posted: August 14, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)