This Study in Healthy Men Tests How Different Doses of BI 894416 Are Taken up in the Body and How Well BI 894416 is Tolerated

NCT03315936 | Completed Phase 1 Results

• 2 other identifiers: 1371-00012016-003470-40
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

This first-in man trial is designed to investigate the safety and tolerability of BI 894416 in healthy male subjects following oral administration of single rising doses. Pharmacokinetics (PK) including dose proportionality after single dosing of BI 894416 as oral solution will be explored, the investigation of PK of BI 894416 as tablet formulation and the exploration of relative bioavailability of BI 894416 as tablet formulation compared to oral solution.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Drug-related Adverse Events in SRD Part

  Percentage of participants with drug-related adverse events (AEs) in SRD part. Percentages are calculated using total number of subjects per treatment as the denominator. Percentages were rounded up to 1 decimal places.

  From drug administration until end of the trial, up to 17 days.

Secondary Outcomes (5)

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

  Pharmacokinetic samples were collected at 2 hours (h) prior drug administration and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72, 96, 168 h after drug administration.

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

  Pharmacokinetic samples were collected at 2 hours (h) prior drug administration and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72, 96, 168 h after drug administration.

• 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) in Rel BA Part

  Pharmacokinetic samples were collected at 2 hours (h) prior drug administration and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 h after drug administration.

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

  Pharmacokinetic samples were collected at 2 hours (h) prior drug administration and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 h after drug administration.

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

  Pharmacokinetic samples were collected at 2 hours (h) prior drug administration and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 h after drug administration.

Study Arms (10)

Placebo matching BI 894416 (SRD Part)

PLACEBO COMPARATOR

Single Rising Dose (SRD) Part

Drug: Placebo

BI 894416 3 milligram (mg)

EXPERIMENTAL

SRD Part

Drug: BI 894416

BI 894416 10 mg

EXPERIMENTAL

SRD Part

Drug: BI 894416

BI 894416 20 mg

EXPERIMENTAL

SRD Part

Drug: BI 894416

BI 894416 30 mg

EXPERIMENTAL

SRD Part

Drug: BI 894416

BI 894416 40 mg

EXPERIMENTAL

SRD Part

Drug: BI 894416

BI 894416 54 mg

EXPERIMENTAL

SRD Part

Drug: BI 894416

BI 894416 70 mg

EXPERIMENTAL

SRD Part

Drug: BI 894416

BI 894416 10mg tb / 10mg PfOS / 40mg tb

EXPERIMENTAL

BI 894416 10 mg tablet (tb) / BI 894416 10 mg powder for oral solution (PfOS) / BI 894416 4\*10 mg tablets. Relative bioavailability (rel BA) part

Drug: BI 894416

BI 894416 10mg PfOS / 10mg tb / 40mg tb

EXPERIMENTAL

BI 894416 10 mg powder for oral solution (PfOS) / BI 894416 10 mg tablet (tb) / BI 894416 4\*10 mg tablets. Relative bioavailability (rel BA) part.

Drug: BI 894416

Interventions

BI 894416 DRUG

powder for oral solution

BI 894416 10 mg; BI 894416 10mg PfOS / 10mg tb / 40mg tb; BI 894416 10mg tb / 10mg PfOS / 40mg tb; BI 894416 20 mg; BI 894416 3 milligram (mg); BI 894416 30 mg; BI 894416 40 mg; BI 894416 54 mg; BI 894416 70 mg

Placebo DRUG

Oral solution

Placebo matching BI 894416 (SRD Part)

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, 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 (incl.)
• Body Mass Index (BMI) of 18.5 to 29.9 kg/m2 (incl.)
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (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) is deviating from normal and judged 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 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 judged as clinically relevant by the investigator
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and 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 prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation)
• Participation in another trial where an investigational drug has been administered within 60 days prior to planned administration of trial medication, or current participation in another trial involving administration of investigational drug
• Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
• Inability to refrain from smoking on specified trial days
• Alcohol abuse (consumption of more than 30 g per day)

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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2017
• First Posted: October 20, 2017
• Study Start: November 2, 2017
• Primary Completion: September 10, 2018
• Study Completion: September 10, 2018
• Last Updated: March 18, 2024
• Results First Posted: March 18, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)